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NCT04904549 · ClinicalTrials.gov registry record · Phase 3
Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 23,670
- Enrollment target
NCT04904549 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 23,670 participants.
The verdict
NCT04904549, a Phase 3 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 23,670 participants
- Enrollment target
Study Summary
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: * For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) * For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) * For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
- BIOLOGICAL SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)
- BIOLOGICAL SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23,670 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04904549
The ClinicalTrials.gov registry entry for NCT04904549 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 23,670 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 4 interventions - of which Placebo is the first listed.
NCT04904549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04904549 about?
NCT04904549 is a clinical study titled "Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older". The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years ...
What is the current status of trial NCT04904549?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23,670 participants. The study started on 2021-05-26. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT04904549?
The interventions under investigation include: Placebo (BIOLOGICAL), SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series) (BIOLOGICAL), SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series) (BIOLOGICAL), SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT04904549?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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