Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
Public ClinicalTrials.gov record NCT05004181. 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.
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Official title
A Phase II Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Monovalent and Multivalent RNA-based Vaccines in Healthy Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants.
Study identification
- NCT ID
- NCT05004181
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,380 participants
Conditions and interventions
Interventions
- BNT162b2 Biological
- Multivalent BNT162b2 (B.1.1.7 + B.1.617.2) Biological
- Monovalent BNT162b2 (B.1.1.7) Biological
- Monovalent BNT162b2 (B.1.617.2) Biological
- Monovalent BNT162b2 (B.1.1.529.1) Biological
- Observational Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- 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
- Aug 25, 2021 (Actual)
- Primary completion
- Aug 16, 2023 (Actual)
- Completion
- Oct 4, 2023 (Actual)
- Last update posted
- Nov 22, 2024
2021 – 2023
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Collaborative Neuroscience Network LLC | Long Beach | California | 90806 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Clinical Research Consulting, Llc | Milford | Connecticut | 06460 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Meridian Clinical Research | Savannah | Georgia | 31406 | — |
| Medpharmics, LLC | Gulfport | Mississippi | 39503 | — |
| Amici Clinical Research | Warren Township | New Jersey | 07059 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | — |
| ARC Clinical Research | Austin | Texas | 78745 | — |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | — |
| Clinical Trials of Texas Inc. | San Antonio | Texas | 78229 | — |
| Diagnostics Research Group | San Antonio | Texas | 78229 | — |
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 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05004181, 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 Nov 22, 2024 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05004181 live on ClinicalTrials.gov.