A Study of COVID-19 Vaccine(s) in Children and Adults
Public ClinicalTrials.gov record NCT07798648. 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 CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN CHILDREN AND ADULTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older. This study is seeking participants who: * are medically stable * have not had a recent COVID-19 infection or a recent COVID-19 vaccination * have not received certain routine vaccines recently * participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19. Participants in Cohort 1 of this study will receive a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. The study team and participants will know which injection they receive. Participants in Cohort 2 of this study will randomly receive 1 injection into their upper arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive. Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.
Study identification
- NCT ID
- NCT07798648
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 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
- Aug 30, 2026
- Primary completion
- Apr 20, 2027
- Completion
- Apr 20, 2027
- Last update posted
- Sep 27, 2026
2026 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| C & R Research Servcies USA, Inc. | Homestead | Florida | 33030 | Recruiting |
| Indago Research & Health Center, Inc | Miami Lakes | Florida | 33016 | Recruiting |
| AGILE Clinical Research Trials, LLC | Atlanta | Georgia | 30328 | Recruiting |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | Recruiting |
| Kentucky Pediatric /Adult Research | Bardstown | Kentucky | 40004 | Recruiting |
| Dayton Clinical Research | Dayton | Ohio | 45409 | Recruiting |
| Senders Pediatrics | South Euclid | Ohio | 44121 | Recruiting |
| DM Clinical Research | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Cedar Health Research | Dallas | Texas | 75251 | Recruiting |
| Cedar Health Research | Euless | Texas | 76040 | Recruiting |
| DM Clinical Research-Cyfair | Houston | Texas | 77065 | Recruiting |
| DM Clinical Research | Tomball | Texas | 77375 | Recruiting |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | Recruiting |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | Recruiting |
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 NCT07798648, 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 Sep 27, 2026 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07798648 live on ClinicalTrials.gov.