Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04762680 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2275% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form (CRF) in terms of
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 |
What the finished NCT04762680 record still lists
NCT04762680 is an interventional study that assigns participants to a tested intervention. Its 3,159 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2275% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04762680's enrollment target sits among peer trials
3,159 6th of 2000 higher than 1,995 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06224205 · 3,150 participants · NA
Digital Detection of Dementia (D Cubed) Studies: D3
- NCT02043457 · 3,200 participants
Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
- NCT04045665 · 3,200 participants · Phase 3
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
- NCT05381766 · 3,200 participants · NA
Building Access to Food Through Systems and Solidarity
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI