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NCT04762680 · ClinicalTrials.gov registry record · Phase 2
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 3,159
- Enrollment target
NCT04762680 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,159 participants.
The verdict
NCT04762680, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3,159 participants
- Enrollment target
Study Summary
The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.
Interventions
- BIOLOGICAL SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
- BIOLOGICAL SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
- BIOLOGICAL SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
- BIOLOGICAL SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
- BIOLOGICAL SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,159 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2023-06-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04762680
The ClinicalTrials.gov registry entry for NCT04762680 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3,159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1 is the first listed.
NCT04762680 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04762680 about?
NCT04762680 is a clinical study titled "Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older". The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-...
What is the current status of trial NCT04762680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3,159 participants. The study started on 2021-02-24. Estimated completion is 2023-06-29.
What interventions are being tested in trial NCT04762680?
The interventions under investigation include: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1 (BIOLOGICAL), SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 (BIOLOGICAL), SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3 (BIOLOGICAL), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A (BIOLOGICAL), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04762680?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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