Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
Public ClinicalTrials.gov record NCT05541861. 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 Exploratory Phase I, Randomized, Observer-blind, Active-controlled, Dose-escalation Trial Evaluating the Safety, Tolerability, and Immunogenicity of an Investigational RNA-based SARS-CoV-2 Vaccine in COVID-19 Vaccine Experienced Healthy Adults
Study identification
- NCT ID
- NCT05541861
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 383 participants
Conditions and interventions
Conditions
Interventions
- BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg Biological
- BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg Biological
- BNT162b4 10 mcg Biological
- BNT162b4 15 mcg Biological
- BNT162b4 30 mcg Biological
- BNT162b4 5 mcg 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
- Nov 7, 2022
- Primary completion
- Nov 21, 2024
- Completion
- Nov 21, 2024
- Last update posted
- Jan 12, 2026
2022 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Tempe | Arizona | 85281 | — |
| Hoag Hospital | Newport Beach | California | 92663 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | — |
| Cenexel RCA (Research Centers of America) | Hollywood | Florida | 33024 | — |
| Research Institute of South Florida, Inc. | Miami | Florida | 33173 | — |
| Great Lakes Clinical Trials LLC - Andersonville | Chicago | Illinois | 60640 | — |
| Johnson County Clin-Trials, Inc. (JCCT) | Lenexa | Kansas | 66219 | — |
| University of Kentucky Center for Clinical and Translational Science (outpatient clinic) | Lexington | Kentucky | 40536 | — |
| Alliance for Multispecialty Research, LLC (Kansas) | Kansas City | Missouri | 64114 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | — |
| Clinical Trials of Texas, LLC / Flourish Research | San Antonio | Texas | 78229 | — |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
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 NCT05541861, 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 Jan 12, 2026 · Synced May 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05541861 live on ClinicalTrials.gov.