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| Column | Value |
|---|---|
| Trial registration number | NCT04894435 |
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Full text link
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-20 |
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Recruitment status
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
inclusion criteria: participant is willing and able to give written informed consent to participate in the study age 18 years of age or older in good health or with mild or moderate stable co-morbidities at the time of enrolment able and willing to complete all the scheduled study procedures during the whole study follow-up period 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) 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) mosaic -1 vaccine naïve subgroups: have not received an authorized covid-19 vaccine at any time 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) 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) |
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Exclusion criteria
Last imported at : Jan. 15, 2022, 10 a.m. Source : ClinicalTrials.gov |
inability or unwillingness of participant or legally acceptable representative to give written informed consent 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) 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 allergy to any study vaccine or any active substance in a study vaccine bleeding disorder or history of significant bleeding following im injections or venipuncture continuous use of anticoagulants a history of anaphylaxis to a previous vaccine pregnancy or intent to become pregnant during the study or within 3 months of the last dose of study vaccine mosaic-1: history of laboratory-confirmed covid-19 disease prior to enrolment by participant report administration of a live virus vaccine within 4 weeks prior to study vaccine receipt. |
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Number of arms
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
28 |
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Funding
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Canadian Immunization Research Network |
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Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
99 |
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Countries
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Canada |
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Type of patients
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
669 |
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primary outcome
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
Antibody response to SARS-CoV-2 S protein after 2 doses;Antibody response to SARS-CoV-2 S protein after 2 doses;Antibody response to SARS-CoV-2 S protein after 3 doses;Antibody response to SARS-CoV-2 S protein after 4 doses |
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Notes
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : March 22, 2023, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Moderna - 28 Days apart", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Moderna - 112 days apart", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 3: Moderna, Pfizer/BioNTech - 28 days apart", "treatment_id": 1431, "treatment_name": "Bnt162b2+mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4: Moderna, Pfizer/BioNTech - 112 days apart", "treatment_id": 1431, "treatment_name": "Bnt162b2+mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 5: Pfizer/BioNTech, Pfizer/BioNTech - 28 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 6: Pfizer/BioNTech, Pfizer/BioNTech - 112 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 7: Pfizer/BioNTech, Moderna - 28 days apart", "treatment_id": 1431, "treatment_name": "Bnt162b2+mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 8: Pfizer/BioNTech, Moderna - 112 days apart", "treatment_id": 1431, "treatment_name": "Bnt162b2+mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 9: Astra Zeneca, Moderna - 28 days apart", "treatment_id": 2702, "treatment_name": "Chadox1-s+mrna-1273", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 10: Astra Zeneca, Moderna - 112 days apart", "treatment_id": 2702, "treatment_name": "Chadox1-s+mrna-1273", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 11: Astra Zeneca, Pfizer/BioNTech - 28 days apart", "treatment_id": 2703, "treatment_name": "Bnt162b2+chadox1-s", "treatment_type": "Rna based vaccine+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " Group 12: Astra Zeneca, Pfizer/BioNTech - 112 days apart", "treatment_id": 2703, "treatment_name": "Bnt162b2+chadox1-s", "treatment_type": "Rna based vaccine+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 1b", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 2b", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 3b", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4b", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 5b", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 6b", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 7b", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 8b", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 9b", "treatment_id": 2704, "treatment_name": "Mt-2766", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 1c", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 2c", "treatment_id": 2704, "treatment_name": "Mt-2766", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 3c", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4c", "treatment_id": 2704, "treatment_name": "Mt-2766", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 5c", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 6c", "treatment_id": 2704, "treatment_name": "Mt-2766", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 7c", "treatment_id": 2704, "treatment_name": "Mt-2766", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}] |