A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Public ClinicalTrials.gov record NCT04713553. 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
A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE
Study identification
- NCT ID
- NCT04713553
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 1,574 participants
Conditions and interventions
Conditions
Interventions
- BNT162b2 Biological
- BNT162b2.B.1.351 Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Years to 50 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
- Feb 14, 2021
- Primary completion
- Jul 21, 2021
- Completion
- Jul 21, 2021
- Last update posted
- Dec 21, 2022
2021
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente Oakland | Oakland | California | 94611 | — |
| Clinical Research Consulting | Milford | Connecticut | 06460 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Solaris Clinical Research | Meridian | Idaho | 83646 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| Amici Clinical Research LLC | Raritan | New Jersey | 08869 | — |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45206 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | — |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
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 NCT04713553, 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 Dec 21, 2022 · Synced May 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04713553 live on ClinicalTrials.gov.