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SafeTy and Efficacy of Protective COVID-19 Vaccines
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SafeTy and Efficacy of Protective COVID-19 Vaccines

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Datasets -
Variables -
Start Year
2020
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Investigators Contacts
  • Prof. Michael Brudno
    University of Toronto
  • Dr. Christopher Graham
    Trillium Health Partners
  • Dr. Allison McGeer
    Lunenfeld-Tanenbaum Research Institute
  • Dr. Sharon Walmsley
    University Health Network
  • Dr. Bradley Wouters
    University Health Network
  • Dr. Amit Oza
    University Health Network
  • Dr. Paula Rochon
    Women’s College Research Institute
  • Dr. Sharon Walmsley
    University Health Network

Design

Study design
Cohort
Follow Up
Participants are followed for 48 weeks after final vaccine dose for COVID-19 (at 7 days and 3 weeks post-1st vaccine dose, and 2 weeks, 12 weeks, 24 weeks post-2nd vaccine dose), then followed-up monthly. Participants also kept an eDiary for a 7-day period after each vaccine dose or booster throughout the study.

Recruitment

Recruitment Target
  • Individuals

Number of Participants

Number of Participants
1,300
Number of Participants with Biological Samples

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
30
Maximum age
50
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
Other Criteria
Inclusion: Individuals who can speak, read and understand English (or have a trusted individual to help with study procedures).
Exclusion:
  • Individuals who are less than 30 years or those 51-69 years.
  • Those who are unable to complete the study protocols in English either alone or with the assistance of a trusted individual with an electronic device.
  • Participants who enroll but do not receive any dose of the vaccine.

    • Recruitment

    Sources of recruitment
    • General population
    General Population
    • Volunteer enrolment
    Supplementary Information
    A random sample of emails of persons registering for vaccination at an Ontario center who provide their email and consent to be contacted for research in the target population age groups will be forwarded by the Ministry of Ontario to the study site. The study site in turn will forward the email blast electronically to the participants on the list directing them to the STOPCoV study website. Pamphlets and posters describing the study and providing the website and contact information will be made available at Toronto vaccine distribution centers, primary care offices, pharmacies and community organizations supporting vaccine uptake.

    Number of Participants

    Number of Participants
    400
    Number of Participants with Biological Samples
    Data Collection Events
    # Name Description Start End
    0 StopCoV - 30-50 year olds - Baseline Information was collected electronically about demographics- age, gender, 3-digit postal code, comorbidity (to include previous COVID-19 infection and testing, diabetes, hypertension, ... 2020
    1 StopCoV - 30-50 year olds - eDiary Information was collected through an electronic diary to record the date of their vaccination (or any changes) and any booster and to respond to questions about potential adverse events including ... 2020
    2 StopCoV - 30-50 year olds - 7 days post 1st vaccine dose Dried Blood Spot (DBS) specimens were collected within 7 days of initial vaccine dose (or as soon after the initial vaccine dose as possible and not longer than 7 days). 2021-03
    3 StopCoV - 30-50 year olds - 3 weeks post 1st vaccine dose Dried Blood Spot (DBS) specimens were collected . 2021-03
    4 StopCoV - 30-50 year olds - Pre-2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. This is collected only if the interval between the two doses is prolonged beyond 28 days. 2021-03
    5 StopCoV - 30-50 year olds - 2 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected . 2021-04
    6 StopCoV - 30-50 year olds - 12 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2021-07
    7 StopCoV - 30-50 year olds - 24 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2021-10
    8 StopCoV - 30-50 year olds - 36 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2022-01
    9 StopCoV - 30-50 year olds - 48 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2022-04
    10 StopCoV - 30-50 year olds - Follow-up 1 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-04 2021-04
    11 StopCoV - 30-50 year olds - Follow-up 2 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-05 2021-05
    12 StopCoV - 30-50 year olds - Follow-up 3 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-06 2021-06
    13 StopCoV - 30-50 year olds - Follow-up 4 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-07 2021-07
    14 StopCoV - 30-50 year olds - Follow-up 5 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-08 2021-08
    15 StopCoV - 30-50 year olds - Follow-up 6 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-09 2021-09
    16 StopCoV - 30-50 year olds - Follow-up 7 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-10 2021-10
    17 StopCoV - 30-50 year olds - Follow-up 8 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-11 2021-11
    18 StopCoV - 30-50 year olds - Follow-up 9 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-12 2021-12
    19 StopCoV - 30-50 year olds - Follow-up 10 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-01 2022-01
    20 StopCoV - 30-50 year olds - Follow-up 11 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-02 2022-02
    21 StopCoV - 30-50 year olds - Follow-up 12 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-03 2022-03
    22 StopCoV - 30-50 year olds - Follow-up 13 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-04 2022-04
    Selection Criteria
    Minimum age
    70
    Newborns
    Twins
    Countries
    • Canada
    Territory
    Ethnic Origin
    Health Status
    Other Criteria
    Inclusion: Individuals who can speak, read and understand English (or have a trusted individual to help with study procedures).
    Exclusion:
  • Individuals who are less than < 30 years or those 51-69 years
  • Those who are unable to complete the study protocols in English either alone or with the assistance of a trusted individual with an electronic device.
  • Participants will be excluded if they who enrol but do not receive any dose of the vaccine.

    • Recruitment

    Sources of recruitment
    • General population
    General Population
    • Volunteer enrolment
    Supplementary Information
    A random sample of emails of persons registering for vaccination at an Ontario center who provide their email and consent to be contacted for research in the target population age groups will be forwarded by the Ministry of Ontario to the study site. The study site in turn will forward the email blast electronically to the participants on the list directing them to the STOPCoV study website. Participants were also recruited through three email blasts that were done through ZOOMER media to CARP- Canadian association of retired persons. Pamphlets and posters describing the study and providing the website and contact information will be made available at Toronto vaccine distribution centers, primary care offices, pharmacies and community organizations supporting vaccine uptake.

    Number of Participants

    Number of Participants
    900
    Number of Participants with Biological Samples
    Data Collection Events
    # Name Description Start End
    0 StopCoV - 70 years and older - Baseline Information was collected electronically about demographics- age, gender, 3-digit postal code, comorbidity (to include previous COVID-19 infection and testing, diabetes, hypertension, ... 2020
    1 StopCoV - 70 years and older - eDiary Information was collected through an electronic diary to record the date of their vaccination (or any changes) and any booster and to respond to questions about potential adverse events including ... 2020
    2 StopCoV - 70 years and older - 7 days post 1st vaccine dose Dried Blood Spot (DBS) specimens were collected within 7 days of initial vaccine dose (or as soon after the initial vaccine dose as possible and not longer than 7 days). 2021-03
    3 StopCoV - 70 years and older - 3 weeks post 1st vaccine dose Dried Blood Spot (DBS) specimens were collected. 2021-03
    4 StopCoV - 70 years and older - Pre-2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. This is collected only if the interval between the two doses is prolonged beyond 28 days. 2021-05
    5 StopCoV - 70 years and older - 2 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2021-04
    6 StopCoV - 70 years and older - 12 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2021-07
    7 StopCoV - 70 years and older - 24 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2021-10
    8 StopCoV - 70 years and older - 36 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2022-01
    9 StopCoV - 70 years and older - 48 weeks post 2nd vaccine dose Dried Blood Spot (DBS) specimens were collected. 2022-04
    10 StopCoV - 70 years and older - Follow-up 1 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-04 2021-04
    11 StopCoV - 70 years and older - Follow-up 2 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-05 2021-05
    12 StopCoV - 70 years and older - Follow-up 3 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-06 2021-06
    13 StopCoV - 70 years and older - Follow-up 4 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-07 2021-07
    14 StopCoV - 70 years and older - Follow-up 5 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-08 2021-08
    15 StopCoV - 70 years and older - Follow-up 6 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-09 2021-09
    16 StopCoV - 70 years and older - Follow-up 7 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-10 2021-10
    17 StopCoV - 70 years and older - Follow-up 8 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-11 2021-11
    18 StopCoV - 70 years and older - Follow-up 9 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2021-12 2021-12
    19 StopCoV - 70 years and older - Follow-up 10 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-01 2022-01
    20 StopCoV - 70 years and older - Follow-up 11 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-02 2022-02
    21 StopCoV - 70 years and older - Follow-up 12 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-03 2022-03
    22 StopCoV - 70 years and older - Follow-up 13 Information was collected on long term vaccine adverse events and breakthrough COVID infection. 2022-04 2022-04

    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
    Education
    Ethnicity, race and religion

    Lifestyle and behaviours

    Tobacco

    Diseases

    Certain infectious and parasitic diseases (A00-B99)
    Neoplasms (C00-D48)
    Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
    Endocrine, nutritional and metabolic diseases (E00-E90)
    Diseases of the nervous system (G00-G99)
    Diseases of the circulatory system (I00-I99)
    Diseases of the respiratory system (J00-J99)
    Diseases of the digestive system (K00-K93)
    Diseases of the genitourinary system (N00-N99)
    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 nervous and musculoskeletal systems (R25-R29)
    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

    Surgical interventions
    Laboratory diagnosis interventions
    Other and unspecified non-pharmacological interventions

    Health and community care services utilization

    Hospitalizations

    Physical measures and assessments

    Anthropometry
    Other physical measures and assessments

    Administrative information

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