A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Public ClinicalTrials.gov record NCT04816669. 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 FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. * 2-dose schedule (separated by 21 days) * At a dose of 30µg (as studied in the Phase 2/3 study C4591001) * In healthy adults 18 through 55 years of age * The duration of the study for each participant will be approximately 2 months (3 visits in total) * The study will be conducted in the United States
Study identification
- NCT ID
- NCT04816669
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 629 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 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
- Apr 1, 2021 (Actual)
- Primary completion
- Dec 1, 2021 (Actual)
- Completion
- Dec 2, 2021 (Actual)
- Last update posted
- Dec 23, 2022
2021
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | — |
| 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 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Amici Clinical Research LLC | Raritan | New Jersey | 08869 | — |
| Accellacare (formerly PMG Research of Wilmington, LLC) | Wilmington | North Carolina | 28401 | — |
| Aventiv Research Inc | Columbus | Ohio | 43213 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
| DM Clinical Research (Administrative and Storage Office only) | Tomball | Texas | 77375 | — |
| Martin Diagnostic Clinic | 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 | — |
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 NCT04816669, 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 23, 2022 · 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 NCT04816669 live on ClinicalTrials.gov.