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
Public ClinicalTrials.gov record NCT04762680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04762680
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 3,159 participants
Conditions and interventions
Conditions
Interventions
- 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
- SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B Biological
- SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1 Biological
- SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2 Biological
- SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3 Biological
- SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4 Biological
- SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2021 (Actual)
- Primary completion
- Jun 29, 2023 (Actual)
- Completion
- Jun 29, 2023 (Actual)
- Last update posted
- Sep 18, 2025
2021 – 2023
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synexus - Clinical Research Advantage, Inc. Site Number : 8400270 | Birmingham | Alabama | 35205 | — |
| Synexus Chandler Site Number : 8400251 | Chandler | Arizona | 85225 | — |
| Synexus - Glendale. Site Number : 8400271 | Glendale | Arizona | 85306 | — |
| Baptist Health Center for Clinical Research Site Number : 8400077 | Little Rock | Arkansas | 72205 | — |
| Charles R. Drew University of Medicine and Science Site Number : 8400220 | Los Angeles | California | 90059 | — |
| Peninsula Research Associates, Inc. Site Number : 8400094 | Rolling Hills Estates | California | 90274 | — |
| Optimal Research Site Number : 8400173 | San Diego | California | 92108 | — |
| Yale University Site Number : 8400239 | New Haven | Connecticut | 06510 | — |
| The George Washington University Site Number : 8400212 | Washington D.C. | District of Columbia | 20037 | — |
| Cenexel Research Centers of America Site Number : 8400089 | Hollywood | Florida | 33024 | — |
| Optimal Research, LLC Site Number : 8400057 | Melbourne | Florida | 32934 | — |
| Synexus Clinical Research US, Inc. - Orlando Site Number : 8400179 | Orlando | Florida | 32806 | — |
| Emory University Decatur Site Number : 8400201 | Decatur | Georgia | 30030 | — |
| Chicago Clinical Research Institute, Inc. Site Number : 8400269 | Chicago | Illinois | 60607 | — |
| Optimal Research Site Number : 8400187 | Peoria | Illinois | 61614 | — |
| Synexus Clinical Research Evansville Site Number : 8400272 | Evansville | Indiana | 47714 | — |
| Research Works INC Site Number : 8400045 | New Orleans | Louisiana | 70125 | — |
| Optimal Research, LLC Rockville Site Number : 8400048 | Rockville | Maryland | 20850 | — |
| Brigham and Women's Hospital Site Number : 8400199 | Boston | Massachusetts | 02115 | — |
| Synexus St. Louis Site Number : 8400100 | St Louis | Missouri | 63141 | — |
| Velocity Clinical Research, Omaha Site Number : 8400030 | Omaha | Nebraska | 68134 | — |
| Holy Name Medical Center Site Number : 8400072 | Teaneck | New Jersey | 07666 | — |
| NYU VC-Augustana Site Number : 8400267 | Brooklyn | New York | 11220 | — |
| New York University Langone Vaccine Center Site Number : 8400230 | New York | New York | 10016 | — |
| Columbia University Irving Medical Center Site Number : 8400203 | New York | New York | 10032 | — |
| University of Rochester Site Number : 8400207 | Rochester | New York | 14642 | — |
| University of Pittsburgh Site Number : 8400233 | Pittsburgh | Pennsylvania | 15213 | — |
| Coastal Carolina Research Center Site Number : 8400097 | North Charleston | South Carolina | 29405 | — |
| American Indian Clinical Trials Research Network Site Number : 8400204 | Rapid City | South Dakota | 57701 | — |
| AES Austin Site Number : 8400191 | Austin | Texas | 78744 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04762680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04762680 live on ClinicalTrials.gov.