Individual Study / MOSAIC

Immunogenicity and Adverse Events Following Immunization with Alternate Schedules of Authorized COVID-19 Vaccines in Canada: MOSAIC study (Mix and match of the second cOvid-19 vaccine dose for SAfety and ImmunogeniCity)
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Immunogenicity and Adverse Events Following Immunization with Alternate Schedules of Authorized COVID-19 Vaccines in Canada: MOSAIC study (Mix and match of the second cOvid-19 vaccine dose for SAfety and ImmunogeniCity)

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Datasets -
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Start Year
2021
End Year
2023
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Investigators Contacts
  • Dr. Joanne Langley
    Dalhousie University
  • Dr. Manish Sadarangani
    BC Children's Hospital, University of British Columbia
  • Dr. Shelly Bolotin
    University of Toronto
  • Dr. Todd Hatchette
    Dalhousie University
  • Dr. Vanessa Tran
    University of Toronto
  • Dr. Tania Watts
    University of Toronto
  • Dr. Galit Alter
    Massachusetts General Hospital
  • Terri Cairo
    IWK Health Centre

Design

Study design
Clinical trial
Follow Up
Participants from the vaccine naïve cohort were followed-up for 12 months. They were first seen the day of 1st dose of vaccination. Then, participants in group 1, 3, 5 and 7 were followed-up after 28, 56, 140 and 365 days of first dose, while participants in group 2, 4, 6 and 8 were followed-up after 28, 112, 140 and 365 days.

Participants from the vaccine exposed cohort were followed-up for 10-11 months. They were first seen 28 days after their first dose of vaccination. Then, participants in group 1, 3, 5, 7, 9 and 11 were followed-up after 56, 140 and 365 days of first dose of vaccination, while participants in group 2, 4, 6, 8, 10 and 12 were followed-up after 112, 140 and 365 days.

Recruitment

Recruitment Target
  • Individuals

Number of Participants

Number of Participants
1,200
Number of Participants with Biological Samples
1,200
Supplementary Information
Vaccine naïve cohorts: 240 participants
Vaccine exposed cohorts: 960 participants

Access

Availability of data and biosamples

Possible Access to Data
Possible Access to Biosamples
Other
Yes
No
Not applicable
Don't know

Timeline

Populations

Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 1 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 1 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 1 - Visit 2 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, adverse ... 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 1 - Visit 3 This visit took place 56 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 vaccine acceptability and adverse events (diary card) ... 2021-08 2021-08
4 MOSAIC - Vaccine Naïve Group 1 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 test and symptoms was collected. Blood samples were ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 1 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 1 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 2 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 2 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 2 - Visit 2 This visit took place 28 days after the first dose of vaccination. Information about COVID-19 test and symptoms, and adverse events (from diary card) was collected. Blood samples were collected. 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 2 - Visit 3 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, and ... 2021-10 2021-10
4 MOSAIC - Vaccine Naïve Group 2 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (diary card) and COVID-19 acceptability was ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 2 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 2 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 3 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 3 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 3 - Visit 2 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, adverse ... 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 3 - Visit 3 This visit took place 56 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 vaccine acceptability and adverse events (diary card) ... 2021-08 2021-08
4 MOSAIC - Vaccine Naïve Group 3 - Visit 4 Visit 4 took place 140 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 test and symptoms was collected. Blood samples were ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 3 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 3 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 4 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 4 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 4 - Visit 2 This visit took place 28 days after the first dose of vaccination. Information about COVID-19 test and symptoms, and adverse events (from diary card) was collected. Blood samples were collected. 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 4 - Visit 3 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, and ... 2021-10 2021-10
4 MOSAIC - Vaccine Naïve Group 4 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (diary card) and COVID-19 acceptability was ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 4 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 4 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 5 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 5 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 5 - Visit 2 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, adverse ... 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 5 - Visit 3 This visit took place 56 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 vaccine acceptability and adverse events (diary card) ... 2021-08 2021-08
4 MOSAIC - Vaccine Naïve Group 5 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 test and symptoms was collected. Blood samples were ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 5 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 5 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 6 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 6 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 6 - Visit 2 This visit took place 28 days after the first dose of vaccination. Information about COVID-19 test and symptoms, and adverse events (from diary card) was collected. Blood samples were collected. 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 6 - Visit 3 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, and ... 2021-10 2021-10
4 MOSAIC - Vaccine Naïve Group 6 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (diary card) and COVID-19 acceptability was ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 6 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 6 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 7 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 7 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 7 - Visit 2 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, adverse ... 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 7 - Visit 3 This visit took place 56 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 vaccine acceptability and adverse events (diary card) ... 2021-08 2021-08
4 MOSAIC - Vaccine Naïve Group 7 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 test and symptoms was collected. Blood samples were ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 7 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 7 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have not received an authorized COVID-19 vaccine at any time
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Naïve Group 8 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Naïve Group 8 - Visit 1 The first dose of vaccination is administered at this visit. Information about consent, demographics, height and weight, medical history including current medications, randomization and ... 2021-06 2021-06
2 MOSAIC - Vaccine Naïve Group 8 - Visit 2 This visit took place 28 days after the first dose of vaccination. Information about COVID-19 test and symptoms, and adverse events (from diary card) was collected. Blood samples were collected. 2021-07 2021-07
3 MOSAIC - Vaccine Naïve Group 8 - Visit 3 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, COVID-19 test and symptoms, and ... 2021-10 2021-10
4 MOSAIC - Vaccine Naïve Group 8 - Visit 4 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, COVID-19 test and symptoms was collected. Blood samples were ... 2021-11 2021-11
5 MOSAIC - Vaccine Naïve Group 8 - Visit 5 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications and COVID-19 vaccine acceptability was collected. Blood ... 2022-06 2022-06
6 MOSAIC - Vaccine Naïve Group 8 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 1 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 1 - Visit 1 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about consent, demographics, height and weight, medical history including current ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 1 - Visit 2 This visit took place 56 days after the first dose of vaccination. Information about reaffirmation of consent, medical history including current medications, adverse events (from diary card) and ... 2021-07 2021-07
3 MOSAIC - Vaccine Exposed Group 1 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about consent, medical history including current medications, adverse events, COVID-19 test and symptoms was ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 1 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 1 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 2 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 2 - Visit 1 This visit took place 28 days after the first dose of vaccination. Information about consent, demographics, height and weight, medical history including current medications was collected. Blood ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 2 - Visit 2 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, vaccination, adverse events, ... 2021-09 2021-09
3 MOSAIC - Vaccine Exposed Group 2 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (from diary card) and acceptability of COVID-19 ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 2 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 2 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 3 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 3 - Visit 1 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about consent, demographics, height and weight, medical history including current ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 3 - Visit 2 This visit took place 56 days after the first dose of vaccination. Information about reaffirmation of consent, medical history including current medications, adverse events (from diary card) and ... 2021-07 2021-07
3 MOSAIC - Vaccine Exposed Group 3 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about consent, medical history including current medications, adverse events, COVID-19 test and symptoms was ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 3 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 3 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 4 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 4 - Visit 1 This visit took place 28 days after the first dose of vaccination. Information about consent, demographics, height and weight, medical history including current medications was collected. Blood ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 4 - Visit 2 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, vaccination, adverse events, ... 2021-09 2021-09
3 MOSAIC - Vaccine Exposed Group 4 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (from diary card) and acceptability of COVID-19 ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 4 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 4 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 5 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 5 - Visit 1 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about consent, demographics, height and weight, medical history including current ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 5 - Visit 2 This visit took place 56 days after the first dose of vaccination. Information about reaffirmation of consent, medical history including current medications, adverse events (from diary card) and ... 2021-07 2021-07
3 MOSAIC - Vaccine Exposed Group 5 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about consent, medical history including current medications, adverse events, COVID-19 test and symptoms was ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 5 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 5 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 6 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 6 - Visit 1 This visit took place 28 days after the first dose of vaccination. Information about consent, demographics, height and weight, medical history including current medications was collected. Blood ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 6 - Visit 2 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, vaccination, adverse events, ... 2021-09 2021-09
3 MOSAIC - Vaccine Exposed Group 6 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (from diary card) and acceptability of COVID-19 ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 6 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 6 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 7 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 7 - Visit 1 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about consent, demographics, height and weight, medical history including current ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 7 - Visit 2 This visit took place 56 days after the first dose of vaccination. Information about reaffirmation of consent, medical history including current medications, adverse events (from diary card) and ... 2021-07 2021-07
3 MOSAIC - Vaccine Exposed Group 7 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about consent, medical history including current medications, adverse events, COVID-19 test and symptoms was ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 7 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 7 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 8 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 8 - Visit 1 This visit took place 28 days after the first dose of vaccination. Information about consent, demographics, height and weight, medical history including current medications was collected. Blood ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 8 - Visit 2 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, vaccination, adverse events, ... 2021-09 2021-09
3 MOSAIC - Vaccine Exposed Group 8 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (from diary card) and acceptability of COVID-19 ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 8 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 8 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 9 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 9 - Visit 1 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about consent, demographics, height and weight, medical history including current ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 9 - Visit 2 This visit took place 56 days after the first dose of vaccination. Information about reaffirmation of consent, medical history including current medications, adverse events (from diary card) and ... 2021-07 2021-07
3 MOSAIC - Vaccine Exposed Group 9 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about consent, medical history including current medications, adverse events, COVID-19 test and symptoms was ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 9 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 9 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 10 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 10 - Visit 1 This visit took place 28 days after the first dose of vaccination. Information about consent, demographics, height and weight, medical history including current medications was collected. Blood ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 10 - Visit 2 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, vaccination, adverse events, ... 2021-09 2021-09
3 MOSAIC - Vaccine Exposed Group 10 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (from diary card) and acceptability of COVID-19 ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 10 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 10 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 11 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 11 - Visit 1 The second dose of vaccination is administered at this visit (28 days after the first dose). Information about consent, demographics, height and weight, medical history including current ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 11 - Visit 2 This visit took place 56 days after the first dose of vaccination. Information about reaffirmation of consent, medical history including current medications, adverse events (from diary card) and ... 2021-07 2021-07
3 MOSAIC - Vaccine Exposed Group 11 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about consent, medical history including current medications, adverse events, COVID-19 test and symptoms was ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 11 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 11 - Surveillance >Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
    • Inclusion:
    • In good health or with mild or moderate stable co-morbidities.

      Exclusion:
    • Any confirmed or suspected immunosuppressive or immunodeficient state
    • Asplenia, or immunosuppressant medication within the past 6 months except short term oral steroids (≤14 days duration) or topical steroids
    • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
    • Bleeding disorder or history of significant bleeding following IM injections or venipuncture
    • History of laboratory-confirmed COVID-19 disease prior to enrolment.
Other Criteria
    Inclusion:
  • Have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1
  • If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 3 months after the second dose of study vaccine.
    Exclusion:
  • Administration of immunoglobulins and/or any blood products within 3 months,
  • Allergy to any study vaccine or any active substance,
  • Continuous use of anticoagulants,
  • Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine.
Supplementary Information about selection criteria
Participants will be recruited from the communities in which CTN study sites are situated; these are urban centres in Canada. Enrolment will be open to persons of all genders and ethnicities.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants were recruited using social media, media outlets, print and electronic media at vaccination centers, and by contacting persons on existing databases at each site.

Number of Participants

Number of Participants
Number of Participants with Biological Samples
Data Collection Events
# Name Description Start End
0 MOSAIC - Vaccine Exposed Group 12 - Screening Information about consent, eligibility, medical history, concomitant medications and randomization was collected. 2021-05 2021-05
1 MOSAIC - Vaccine Exposed Group 12 - Visit 1 This visit took place 28 days after the first dose of vaccination. Information about consent, demographics, height and weight, medical history including current medications was collected. Blood ... 2021-06 2021-06
2 MOSAIC - Vaccine Exposed Group 12 - Visit 2 The second dose of vaccination is administered at this visit (112 days after the first dose). Information about medical history including current medications, vaccination, adverse events, ... 2021-09 2021-09
3 MOSAIC - Vaccine Exposed Group 12 - Visit 3 This visit took place 140 days after the first dose of vaccination. Information about medical history including current medications, adverse events (from diary card) and acceptability of COVID-19 ... 2021-10 2021-10
4 MOSAIC - Vaccine Exposed Group 12 - Visit 4 This visit took place 365 days after the first dose of vaccination. Information about medical history including current medications, adverse events, COVID-19 test and symptoms, and acceptability ... 2022-03 2022-05
5 MOSAIC - Vaccine Exposed Group 12 - Surveillance Information about medically attended adverse events (MAAE), adverse events of special interest (AESI), serious adverse events (SAE), adverse events following immunization (AEFI) and COVID-19 ... 2021-06 2022-06

Classifications

Socio-demographic and economic characteristics
Lifestyle and behaviours
Birth, pregnancy and reproductive health history
Perception of health, quality of life, development and functional limitations
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Life events, life plans, beliefs and values
Preschool, school and work life
Social environment and relationships
Physical environment
Administrative information

Socio-demographic and economic characteristics

Age/birthdate
Sex/gender
Ethnicity, race and religion

Birth, pregnancy and reproductive health history

Puberty, menstruation, menopause and andropause

Diseases

Certain infectious and parasitic diseases (A00-B99)
Diseases of the respiratory system (J00-J99)
Congenital malformations, deformations and chromosomal abnormalities (Q00-Q99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories

Symptoms and signs

Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving the skin and subcutaneous tissue (R20-R23)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories

Medication and supplements

Medication and supplement intake
Posology and protocol of administration

Non-pharmacological interventions

Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions

Health and community care services utilization

Visits to health professionals
Hospitalizations

Death

Cause of death

Physical measures and assessments

Anthropometry
Circulation and respiration
Skin and subcutaneous tissue
Other physical measures and assessments

Laboratory measures

Biochemistry
Virology

Cognition, personality and psychological measures and assessments

Psychological distress and emotions

Life events, life plans, beliefs and values

Beliefs and values

Administrative information

Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Other administrative information