ClinicalTrials.gov record
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
ClinicalTrials.gov ID: NCT05543616
Public ClinicalTrials.gov record NCT05543616. 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.
ClinicalTrials.gov public records Last synced May 6, 2026, 8:27 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDREN
Study identification
- NCT ID
- NCT05543616
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 4,292 participants
Conditions and interventions
Interventions
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Biological
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Biological
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose Biological
- Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose Biological
- Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose Biological
- Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose Biological
- Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 11 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
- Sep 22, 2022
- Primary completion
- Jul 22, 2026
- Completion
- Jul 22, 2026
- Last update posted
- Apr 12, 2026
2022 – 2026
United States locations
- U.S. sites
- 72
- U.S. states
- 27
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Child Health Research Unit (CHRU) | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Advanced Research Center Inc. | Anaheim | California | 92805 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Kaiser Permanente Oakland | Oakland | California | 94611 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | — |
| Kaiser Permanente Sacramento | Sacramento | California | 95815 | — |
| PediaClinic | Highlands Ranch | Colorado | 80126 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Yale University- Yale Center for Clinical Investigation | New Haven | Connecticut | 06519 | — |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20009 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Velocity Clinical Research, Washington DC | Washington D.C. | District of Columbia | 20016 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | — |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | — |
| Bio-Medical Research LLC | Miami | Florida | 33144 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| SEC Clinical Research | Pensacola | Florida | 32503 | — |
| PAS Research | Tampa | Florida | 33613 | — |
| Emory Children's Center Illness POD | Atlanta | Georgia | 30322 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | — |
| The Iowa Clinic, P.C. | Ankeny | Iowa | 50023 | — |
| The Iowa Clinic, P.C. | West Des Moines | Iowa | 50266 | — |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| AMR Clinical | Newton | Kansas | 67114 | — |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | — |
| Louisiana State University Health Sciences Shreveport | Shreveport | Louisiana | 71101 | — |
| Center for Immunization Research Inpatient Unit | Baltimore | Maryland | 21224 | — |
| Johns Hopkins Center for Immunization Outpatient Clinic | Baltimore | Maryland | 21224 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Boston Medical Center Crosstown Building | Boston | Massachusetts | 02119 | — |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | — |
| Velocity Clinical Research, Hastings | Hastings | Nebraska | 68901 | — |
| Velocity Clinical Research, Lincoln | Lincoln | Nebraska | 68510 | — |
| Children's Hospital & Medical Center | Omaha | Nebraska | 68114 | — |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Velocity Clinical Research, Binghamton | Binghamton | New York | 13905 | — |
| SUNY Downstate Health Sciences University | Brooklyn | New York | 11203 | — |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Atrium Health - Carolinas Medical Center | Charlotte | North Carolina | 28207 | — |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Senders Pediatrics | Cleveland | Ohio | 44121 | — |
| Velocity Clinical Research, Cleveland | Cleveland | Ohio | 44122 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| Dayton Clinical Research | Dayton | Ohio | 45409 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | — |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | — |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | — |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Clinical Research Associates Inc | Nashville | Tennessee | 37203 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Cedar Health Research | Dallas | Texas | 75251 | — |
| Proactive Clinical Research, LLC | Edinburg | Texas | 78539 | — |
| ACRC Trials | Frisco | Texas | 75033 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | — |
| Dr. Ruben Aleman and Associates | McAllen | Texas | 78504 | — |
| ACRC Trials (Administrative Site) | Plano | Texas | 75024 | — |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | — |
| Virginia Research Center | Midlothian | Virginia | 23114 | — |
| Seattle Children's- Building Cure | Seattle | Washington | 98101 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05543616, 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 Apr 12, 2026 · Synced May 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05543616 live on ClinicalTrials.gov.