A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
Public ClinicalTrials.gov record NCT05472038. 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
AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 1/2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b RNA-BASED VACCINE CANDIDATES IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS
Study identification
- NCT ID
- NCT05472038
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 1,453 participants
Conditions and interventions
Conditions
Interventions
- BNT162b2 Bivalent (WT/OMI BA.1) Biological
- BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Biological
- BNT162b5 Bivalent (Original/OMI BA.4/BA.5) Biological
- BNT162b5 Bivalent (WT/OMI BA.2) Biological
- BNT162b6 Bivalent (Original/OMI BA.4/BA.5) Biological
- BNT162b7 Bivalent (Original/OMI BA.4/BA.5) Biological
- BNT162b7 Monovalent (OMI BA.4/BA.5) Biological
Biological
Eligibility (public fields only)
- Age range
- 12 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
- Jul 25, 2022
- Primary completion
- Mar 25, 2024
- Completion
- Mar 25, 2024
- Last update posted
- Sep 30, 2025
2022 – 2024
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Bayview Research Group, LLC | Valley Village | California | 91607 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Clinical Research Consulting | Milford | Connecticut | 06460 | — |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | — |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | — |
| Accellacare - Charlotte | Charlotte | North Carolina | 28211 | — |
| PharmQuest Life Sciences, LLC | Greensboro | North Carolina | 27408 | — |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | — |
| Senders Pediatrics | Cleveland | Ohio | 44121 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| Kaiser Permanente Northwest Center for Health Research | Portland | Oregon | 97227 | — |
| Clinical Neuroscience Solutions Inc. | Memphis | Tennessee | 38119 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Tekton Research, LLC. | Austin | Texas | 78745 | — |
| DM Clinical Research - Bellaire | Houston | Texas | 77081 | — |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | — |
| DM Clinical Research - MDC | Tomball | Texas | 77375 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Virginia Research Center | Midlothian | Virginia | 23114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05472038, 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 30, 2025 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05472038 live on ClinicalTrials.gov.