MOSAIC - Vaccine Naïve Group 7
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 not received an authorized COVID-19 vaccine at any time, and will receive one dose (0,3mL) of Pfizer/BioNTech vaccine via intramuscular injection in the deltoid muscle followed by one dose (0,20 mg/mL) of Moderna vaccine after 28 days.
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 not received an authorized COVID-19 vaccine at any time, and will receive one dose (0,3mL) of Pfizer/BioNTech vaccine via intramuscular injection in the deltoid muscle followed by one dose (0,20 mg/mL) of Moderna vaccine after 28 days.
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Minimum age
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18
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Newborns
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Twins
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Countries
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Territory
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Ethnic Origin
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Health Status
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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.
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Other Criteria
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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.
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Supplementary Information about selection criteria
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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.
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Sources of recruitment
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General Population
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Supplementary Information
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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.
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Number of Participants
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Number of Participants with Biological Samples
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