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)
The primary aim of this study is to assist public health authorities with immunization decision making during the COVID 19 pandemic and in the post-pandemic years, by assessing the immunogenicity and safety of altered schedules for two-dose vaccines and with a heterologous second dose.
The two co-primary objectives are:
* To determine the immune response to SARS-CoV-2 at day 56 (28 days after the second dose of vaccine) while comparing the non-inferiority of 0, 28-day schedules COVID 19 vaccine with heterologous second dose.
* To determine the immune response to SARS-CoV-2 at day 140 (28 days after the last dose in the 0, 112 day schedule) while comparing the non-inferiority of schedules in which the timing of the second dose of vaccine is different (0, 28 days versus 0, 112 days).
The secondary objectives are:
* To assess durability of immune responses in each study group over 12 months.
* To further characterize the immune response to COVID-19 vaccines in schedules with 0, 28 days versus 0, 112 days dosing and heterologous schedules to day 365.
* To describe safety outcomes over 12 months after vaccination.
* To describe acceptability of these vaccines schedules as determined by self-completed participant questionnaires.
Overview
- Acronym
- MOSAIC
- Website
- MOSAIC
- Investigators
-
- Contacts
-
General Design
- Study design
- Clinical trial
- Start - End Year
- 2021 - 2023
- General Information on Follow Up (profile, frequency)
-
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 Target
-
- Individuals
- Number of Participants
- 1,200
- Number of Participants with Biological Samples
- 1,200
- Supplementary information about number of participants
-
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 |
|
Requests should be done through Terri Cairo, not the investigators.
Timeline
Populations
MOSAIC - Vaccine Naïve Group 1
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 two doses (0,20 mg/mL each) of Moderna vaccine via intramuscular injection in the deltoid muscle 28 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 1 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 1 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 1 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 1 - Visit 3 |
|
|
2021 (August) | 2021 (August) |
| 4 | MOSAIC - Vaccine Naïve Group 1 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 1 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 1 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Naïve Group 2
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 two doses (0,20 mg/mL each) of Moderna vaccine via intramuscular injection in the deltoid muscle 112 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 2 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 2 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 2 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 2 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Naïve Group 2 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 2 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 2 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Naïve Group 3
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 (0,20 mg/mL) of Moderna vaccine via intramuscular injection in the deltoid muscle followed by one dose (0,3mL) of Pfizer/BioNTech vaccine after 28 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 3 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 3 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 3 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 3 - Visit 3 |
|
|
2021 (August) | 2021 (August) |
| 4 | MOSAIC - Vaccine Naïve Group 3 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 3 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 3 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Naïve Group 4
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 (0,20 mg/mL) of Moderna vaccine via intramuscular injection in the deltoid muscle followed by one dose (0,3mL) of Pfizer/BioNTech vaccine after 112 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 4 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 4 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 4 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 4 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Naïve Group 4 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 4 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 4 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Naïve 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 not received an authorized COVID-19 vaccine at any time, and will receive two doses (0,3mL each) of Pfizer/BioNTech vaccine via intramuscular injection in the deltoid muscle 28 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 5 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 5 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 5 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 5 - Visit 3 |
|
|
2021 (August) | 2021 (August) |
| 4 | MOSAIC - Vaccine Naïve Group 5 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 5 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 5 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Naïve Group 6
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 two doses (0,3mL each) of Pfizer/BioNTech vaccine via intramuscular injection in the deltoid muscle 112 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 6 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 6 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 6 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 6 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Naïve Group 6 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 6 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 6 - Surveillance |
|
2021 (June) | 2022 (June) |
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.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 7 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 7 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 7 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 7 - Visit 3 |
|
|
2021 (August) | 2021 (August) |
| 4 | MOSAIC - Vaccine Naïve Group 7 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 7 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 7 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Naïve Group 8
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 112 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Naïve Group 8 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Naïve Group 8 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Naïve Group 8 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Naïve Group 8 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Naïve Group 8 - Visit 4 |
|
|
2021 (November) | 2021 (November) |
| 5 | MOSAIC - Vaccine Naïve Group 8 - Visit 5 |
|
|
2022 (June) | 2022 (June) |
| 6 | MOSAIC - Vaccine Naïve Group 8 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 1
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 Moderna vaccine for less than 55 days since injection or are booked to receive the first dose of Moderna vaccine, and will receive the second injection (0,20 mg/mL) of the same vaccine via intramuscular injection in the deltoid muscle 28 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 1 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 1 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 1 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Exposed Group 1 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 1 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 1 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 2
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 Moderna vaccine for less than 55 days since injection or are booked to receive the first dose of Moderna vaccine, and will receive the second injection (0,20 mg/mL) of the same vaccine via intramuscular injection in the deltoid muscle 112 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 2 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 2 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 2 - Visit 2 |
|
|
2021 (September) | 2021 (September) |
| 3 | MOSAIC - Vaccine Exposed Group 2 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 2 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 2 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 3
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 Moderna vaccine for less than 55 days since injection or are booked to receive the first dose of Moderna, and will receive the second injection (0,3mL) of Pfizer/BioNTech via intramuscular injection in the deltoid muscle after 28 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 3 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 3 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 3 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Exposed Group 3 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 3 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 3 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 4
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 Moderna vaccine for less than 55 days since injection or are booked to receive the first dose of Moderna, and will receive the second injection (0,3mL) of Pfizer/BioNTech via intramuscular injection in the deltoid muscle after 112 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 4 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 4 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 4 - Visit 2 |
|
|
2021 (September) | 2021 (September) |
| 3 | MOSAIC - Vaccine Exposed Group 4 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 4 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 4 - Surveillance |
|
2021 (June) | 2022 (June) |
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
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 5 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 5 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 5 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Exposed Group 5 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 5 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 5 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 6
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 mg/mL) of the same vaccine via intramuscular injection in the deltoid muscle 112 days apart.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 6 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 6 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 6 - Visit 2 |
|
|
2021 (September) | 2021 (September) |
| 3 | MOSAIC - Vaccine Exposed Group 6 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 6 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 6 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed 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 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, and will receive the second injection (0,20 mg/mL) of Moderna vaccine via intramuscular injection in the deltoid muscle after 28 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 7 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 7 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 7 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Exposed Group 7 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 7 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 7 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 8
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, and will receive the second injection (0,20 mg/mL) of Moderna vaccine via intramuscular injection in the deltoid muscle after 112 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 8 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 8 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 8 - Visit 2 |
|
|
2021 (September) | 2021 (September) |
| 3 | MOSAIC - Vaccine Exposed Group 8 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 8 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 8 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 9
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 Astra Zeneca vaccine for less than 55 days since injection or are booked to receive the first dose of Astra Zeneca, and will receive the second injection (0,20 mg/mL) of Moderna vaccine via intramuscular injection in the deltoid muscle after 28 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 9 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 9 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 9 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Exposed Group 9 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 9 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 9 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 10
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 Astra Zeneca vaccine for less than 55 days since injection or are booked to receive the first dose of Astra Zeneca, and will receive the second injection (0,20 mg/mL) of Moderna vaccine via intramuscular injection in the deltoid muscle after 112 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 10 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 10 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 10 - Visit 2 |
|
|
2021 (September) | 2021 (September) |
| 3 | MOSAIC - Vaccine Exposed Group 10 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 10 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 10 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 11
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 Astra Zeneca vaccine for less than 55 days since injection or are booked to receive the first dose of Astra Zeneca, and will receive the second injection (0,30 mL) of Pfizer/BioNTech vaccine via intramuscular injection in the deltoid muscle after 28 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 11 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 11 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 11 - Visit 2 |
|
|
2021 (July) | 2021 (July) |
| 3 | MOSAIC - Vaccine Exposed Group 11 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 11 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 11 - Surveillance |
|
2021 (June) | 2022 (June) |
MOSAIC - Vaccine Exposed Group 12
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 Astra Zeneca vaccine for less than 55 days since injection or are booked to receive the first dose of Astra Zeneca, and will receive the second injection (0,30 mL) of Pfizer/BioNTech vaccine via intramuscular injection in the deltoid muscle after 112 days.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- 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.
Sources of Recruitment
- 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.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | MOSAIC - Vaccine Exposed Group 12 - Screening |
|
2021 (May) | 2021 (May) | |
| 1 | MOSAIC - Vaccine Exposed Group 12 - Visit 1 |
|
|
2021 (June) | 2021 (June) |
| 2 | MOSAIC - Vaccine Exposed Group 12 - Visit 2 |
|
|
2021 (September) | 2021 (September) |
| 3 | MOSAIC - Vaccine Exposed Group 12 - Visit 3 |
|
|
2021 (October) | 2021 (October) |
| 4 | MOSAIC - Vaccine Exposed Group 12 - Visit 4 |
|
|
2022 (March) | 2022 (May) |
| 5 | MOSAIC - Vaccine Exposed Group 12 - Surveillance |
|
2021 (June) | 2022 (June) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2024-02-27T14:52:43.298