Maelstrom Research Staging | MOSAIC_VaccineExposed_Group5

MOSAIC_VaccineExposed_Group5_Surveillance

Networks -

Variables -

Associated study MOSAIC Contingency Table

Population

MOSAIC - Vaccine Exposed Group 5

The population is composed of individuals 18 years of age or older, in good health or with mild or moderate stable co-morbidities, who have had one dose of Pfizer/BioNTech vaccine for less than 55 days since injection or are booked to receive the first dose of Pfizer/BioNTech vaccine, and will receive the second injection (0,30 mL) of the same vaccine via intramuscular injection in the deltoid muscle 28 days apart.

Selection Criteria

Minimum age

Newborns

Twins

Countries

Canada

Territory

Ethnic Origin

Health Status

- In good health or with mild or moderate stable co-morbidities.
- 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

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.

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

More info

Data Collection Event

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 illness was collected. Solicited adverse events (SOLAE) (Solicited local (injection-site) and general adverse events) occurring 7-day after injection information was also collected. Results of SARS-CoV-2 testing were obtained from the provincial laboratory database, and documentation of adverse events and COVID-19 associated health sequelae after vaccine receipt were collected from health records.

More info

Collected Dataset / MOSAIC_VaccineExposed_Group5_Surveillance

MOSAIC_VaccineExposed_Group5_Surveillance

Population

MOSAIC - Vaccine Exposed Group 5

Data Collection Event

MOSAIC - Vaccine Exposed Group 5 - Surveillance

Files

Variables Classifications