ClinicalTrials.gov record
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
ClinicalTrials.gov ID: NCT04816643
Public ClinicalTrials.gov record NCT04816643. 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 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.
Study identification
- NCT ID
- NCT04816643
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 11,837 participants
Conditions and interventions
Conditions
Interventions
- Biological/Vaccine: BNT162b2 10mcg Biological
- BNT162b2 20mcg Biological
- BNT162b2 30mcg Biological
- Placebo Other
- Biological/Vaccine: BNT162b2 3mcg Biological
Biological · Other
Eligibility (public fields only)
- Age range
- 6 Months to 15 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
- Mar 23, 2021
- Primary completion
- Oct 3, 2023
- Completion
- Dec 7, 2023
- Last update posted
- May 27, 2026
2021 – 2023
United States locations
- U.S. sites
- 90
- U.S. states
- 31
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - School of Medicine | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| SCPMG/Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Matrix Clinical Research | Los Angeles | California | 90057 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Kaiser Permanente Oakland | Oakland | California | 94611 | — |
| Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University | Palo Alto | California | 94304 | — |
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials | Paramount | California | 90723 | — |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | — |
| Kaiser Permanente Sacramento | Sacramento | California | 95815 | — |
| Kaiser Permanente Santa Clara | Santa Clara | California | 95051 | — |
| Stanford Health Care Investigational Drug Service | Stanford | California | 94305 | — |
| Stanford Health Care | Stanford | California | 94305 | — |
| Bayview Research Group, LLC | Valley Village | California | 91607 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| 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 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | — |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | — |
| Emory Children's Center Illness POD | Atlanta | Georgia | 30322 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Meridian Clinical Research, LLC | Macon | Georgia | 31210 | — |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Solaris Clinical Research | Meridian | Idaho | 83646 | — |
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | — |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| Novak Center for Children's Health | Louisville | Kentucky | 40202 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Louisiana State University Health Sciences Shreveport | Shreveport | Louisiana | 71101 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Michigan Center of Medical Research | Bingham Farms | Michigan | 48025 | — |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Meridian Clinical Research, LLC | Hastings | Nebraska | 68901 | — |
| Velocity Clinical Research, Lincoln | Lincoln | Nebraska | 68510 | — |
| Children's Hospital & Medical Center | Omaha | Nebraska | 68114 | — |
| Children's Physician's Clinic, Spring Valley | Omaha | Nebraska | 68117 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Rutgers University | New Brunswick | New Jersey | 08901 | — |
| Meridian Clinical Research LLC | Binghamton | New York | 13905 | — |
| Advanced Specialty Care | Commack | New York | 11725 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Atrium Health-STRIVE Vaccine Research Clinic | Charlotte | North Carolina | 28207 | — |
| Teen Health Connection (study visits) | Charlotte | North Carolina | 28211 | — |
| Duke University - Main Hospital and Clinics | Durham | North Carolina | 27703 | — |
| Atrium Health-STRIVE Vaccine Research Clinic (study visits) | Matthews | North Carolina | 28105 | — |
| Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio | 45229 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| PriMed Clinical Research | Dayton | Ohio | 45429 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| AHN Erie Health + Wellness Pavillion: West | 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 | — |
| Innovo Research - Austin Regional Clinic | Austin | Texas | 78726 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Cedar Health Research | Dallas | Texas | 75251 | — |
| Bay Colony Pediatrics | Dickinson | Texas | 77539 | — |
| Proactive Clinical Research, LLC | Edinburg | Texas | 78539 | — |
| Village Health Partners (Patient Seen Address) | Frisco | Texas | 75033 | — |
| Helios Clinical Research - HOU | Houston | Texas | 77008 | — |
| Helios Clinical Research | Houston | Texas | 77008 | — |
| HG Pediatrics | Houston | Texas | 77008 | — |
| Van Tran Family Practice | Houston | Texas | 77008 | — |
| Texas Children's Hospital - Clinical Research Center | Houston | Texas | 77030 | — |
| West Houston Clinical Research Services | Houston | Texas | 77055 | — |
| DM Clinical Research - MDC | Houston | Texas | 77065 | — |
| Pediatric Associates | Houston | Texas | 77087 | — |
| 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 | — |
| Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice) | Charlottesville | Virginia | 22902 | — |
| Virginia Research Center | Midlothian | Virginia | 23114 | — |
| 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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04816643, 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 May 27, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04816643 live on ClinicalTrials.gov.