Mix and Match of the COVID-19 Vaccine for Safety and Immunogenicity
NCT ID: NCT04894435
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
669 participants
INTERVENTIONAL
2021-05-20
2025-08-01
Brief Summary
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Detailed Description
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For dose 3, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and plant-based virus-like particle (Medicago Covifenz) are anticipated to be administered 6 months apart. We will assess the immunogenicity of both heterogeneous and heterologous third doses using the Canadian schedule.
For dose 4, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) and plant-based virus-like particle (Medicago Covifenz) are anticipated to be administered 3 months apart. We will assess the immunogenicity of both heterogeneous and heterologous third doses using the Canadian schedule.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
MOSAIC 1:
* Group 1 - M, M - 28 days
* Group 2 - M, M - 112 days
* Group 3 - M, P - 28 days
* Group 4 - M, P - 112 days
* Group 5 - P, P - 28 days
* Group 6 - P, P - 112 days
* Group 7 - P, M - 28 days
* Group 8 - P, M - 112 days
* Group 9 - A, M - 28 days
* Group 10 - A, M - 112 days
* Group 11 - A, P - 28 days
* Group 12 - A, P - 112 days
MOSAIC 2:
* Group 1b - P, P, P
* Group 2b - P, P, M
* Group 3b - M, M, M
* Group 4b - M, M, P
* Group 5b - P and M in any order, M
* Group 6b - P and M in any order, P
* Group 7b - A, P or M, P
* Group 8b - A, P or M, M
* Group 9b - Any vaccine in any order, C (open-label)
MOSAIC 3:
* Group 1c - P, P, P, P
* Group 2c - P, P, P, C
* Group 3c - M, M, M, M
* Group 4c - M, M, M, C
* Group 5c - Any 3 in any order, P or M
* Group 6c - Any 3 in any order, C
* Group 7c - Any 3 in any order, C (open-label)
PREVENTION
TRIPLE
Laboratory staff and statistical analysis personnel will be blinded to which vaccine they are receiving for those in open-label arms.
Study Groups
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Group 1: Moderna, Moderna - 28 Days apart
Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle 28 days apart.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
0, 28 day schedule
Second injection administered 28 days post first injection
Group 2: Moderna, Moderna - 112 days apart
Participants will be blinded and receive two doses (0.20 mg/mL each) of mRNA-1273 SARS-CoV-2 vaccine at 0.20 mg/mL via intramuscular injection in the deltoid muscle 112 days apart.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
0, 112 day schedule
Second injection administered 112 days post first injection
Group 3: Moderna, Pfizer/BioNTech - 28 days apart
Participants will be blinded and receive one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine after 28 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
0, 28 day schedule
Second injection administered 28 days post first injection
Group 4: Moderna, Pfizer/BioNTech - 112 days apart
Participants will be blinded and receive one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine after 112 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
0, 112 day schedule
Second injection administered 112 days post first injection
Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart
Participants will be blinded and receive two doses (0.3mL each) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle 28 days apart.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
0, 28 day schedule
Second injection administered 28 days post first injection
Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart
Participants will be blinded and receive two doses (0.3mL each) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle 112 days apart.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
0, 112 day schedule
Second injection administered 112 days post first injection
Group 7: Pfizer/BioNTech, Moderna - 28 days apart
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 28 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
0, 28 day schedule
Second injection administered 28 days post first injection
Group 8: Pfizer/BioNTech, Moderna - 112 days apart
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 112 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
0, 112 day schedule
Second injection administered 112 days post first injection
Group 9: Astra Zeneca, Moderna - 28 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 28 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
0, 28 day schedule
Second injection administered 28 days post first injection
Group 10: Astra Zeneca, Moderna - 112 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.20 mg/mL) of mRNA-1273 SARS-CoV-2 vaccine after 112 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
0, 112 day schedule
Second injection administered 112 days post first injection
Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3 mL) of BNT162b2 vaccine after 28 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
0, 28 day schedule
Second injection administered 28 days post first injection
Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart
Participants will be blinded and receive one dose (0.5 ml) of ChAdOx1-S \[recombinant\] vaccine via intramuscular injection in the deltoid muscle followed by one dose (0.3 mL) of BNT162b2 vaccine after 112 days.
Vaccine-exposed participants will only be blinded to, and receive, the second injection.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
0, 112 day schedule
Second injection administered 112 days post first injection
Group 1b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Group 2b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Group 3b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Group 4b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Group 5b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Group 6b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Group 7b
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Group 8b
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Group 9b
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Group 1c
Participants will be blinded and receive one dose (0.3mL) of BNT162b2 vaccine via intramuscular injection in the deltoid muscle.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Group 2c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Group 3c
Participants will be blinded and receive one half dose (0.25mL) of mRNA-1273 vaccine via intramuscular injection in the deltoid muscle.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
Group 4c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Group 5c
Participants will be blinded and receive either one dose (0.3mL) of BNT162b2 or one half dose (0.25mL) of mRNA-1273 via intramuscular injection in the deltoid muscle.
mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
Group 6c
Participants will be blinded and receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Group 7c
Participants will receive one dose (0.5mL) of Covifenz vaccine via intramuscular injection in the deltoid muscle.
Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Interventions
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mRNA-1273 SARS-CoV-2 vaccine
Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
BNT162b2
A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
ChAdOx1-S [recombinant]
A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
0, 28 day schedule
Second injection administered 28 days post first injection
0, 112 day schedule
Second injection administered 112 days post first injection
Covifenz
COVIFENZ is an emulsion for intramuscular injection. The 3.75 mcg antigen component of COVIFENZ is a suspension, which must be mixed 1:1 with the 0.25 mL AS03 adjuvant emulsion component prior to administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment
3. Able and willing to complete all the scheduled study procedures during the whole study follow-up period
4. 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 final dose of study vaccine (Please refer to the definition section for a description of child-bearing potential and adequate contraception)
5. MOSAIC-1 Vaccine-exposed subgroups: have received or are booked to receive the first dose of an authorized COVID-19 vaccine in the 55 days prior to Visit 1 (documentation of receipt required)
6. MOSAIC -1 Vaccine naïve subgroups: have not received an authorized COVID-19 vaccine at any time
7. MOSAIC-2 participants have received two doses of COVID-19 vaccines authorized in Canada ≥6 months prior to study vaccine administration (documentation of receipt required)
8. MOSAIC-3 participants have received three doses of COVID-19 vaccines authorized in Canada ≥3 months prior to study vaccine administration (documentation of receipt required)
Exclusion Criteria
2. 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
3. Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin)
4. Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine and for one month after the last dose of study vaccine
5. Allergy to any study vaccine or any active substance in a study vaccine
6. Bleeding disorder or history of significant bleeding following IM injections or venipuncture
7. Continuous use of anticoagulants
8. A history of anaphylaxis to a previous vaccine
9. Pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine
10. MOSAIC-1: History of laboratory-confirmed COVID-19 disease prior to enrolment by participant report
11. Administration of a live virus vaccine within 4 weeks prior to study vaccine receipt.
18 Years
99 Years
ALL
Yes
Sponsors
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Canadian Center for Vaccinology
OTHER
BC Children's Hospital Research Institute
OTHER
Children's Hospital Research Institute of Manitoba
OTHER
CHU de Quebec-Universite Laval
OTHER
Ottawa Hospital Research Institute
OTHER
Ontario Agency for Health Protection and Promotion
OTHER_GOV
University of Toronto
OTHER
Massachusetts General Hospital
OTHER
Interior Health
INDUSTRY
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Canadian Immunization Research Network
NETWORK
Responsible Party
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Principal Investigators
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Joanne Langley
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University/CIRN
Locations
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Royal Inland Hospital
Kamloops, British Columbia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, Canada
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
McGill University Health Centre Vaccine Study Centre
Montreal, Quebec, Canada
CHU de Québec, Université Laval
Québec, Quebec, Canada
Countries
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Other Identifiers
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CT24
Identifier Type: -
Identifier Source: org_study_id
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