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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: Clinical Trial Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
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, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2974% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).
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 |
Why NCT04904549 stopped before completion
NCT04904549 is an interventional study that assigns participants to a tested intervention. Its 23,670 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2974% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04904549 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04904549's enrollment target sits among peer trials
23,670 9th of 2000 higher than 1,992 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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