A Study of COVID-19 Vaccine(s) in Children and Adults
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
- COVID-19 Vaccines
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- BioNTech SE
- Enrolment target
- 700
- Started
- 31 August 2026
- Main results due
- 21 April 2027
- Study sites
- 14
- Registry updated
- 28 September 2026
Can you take part?
- Aged 5 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Key Inclusion criteria: * Participants 5 years of age or older. * Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19. Key Exclusion Criteria: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). * History of myocarditis or pericarditis. * Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment. Refer to the study contact for further eligibility details.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(14)
C & R Research Servcies USA, Inc.
Homestead, Florida, United States
Recruiting
Indago Research & Health Center, Inc
Miami Lakes, Florida, United States
Recruiting
AGILE Clinical Research Trials, LLC
Atlanta, Georgia, United States
Recruiting
East-West Medical Research Institute
Honolulu, Hawaii, United States
Recruiting
Kentucky Pediatric /Adult Research
Bardstown, Kentucky, United States
Recruiting
Dayton Clinical Research
Dayton, Ohio, United States
Recruiting
Senders Pediatrics
South Euclid, Ohio, United States
Recruiting
DM Clinical Research
Philadelphia, Pennsylvania, United States
Recruiting
Cedar Health Research
Dallas, Texas, United States
Recruiting
Cedar Health Research
Euless, Texas, United States
Recruiting
DM Clinical Research-Cyfair
Houston, Texas, United States
Recruiting
DM Clinical Research
Tomball, Texas, United States
Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Recruiting
Showing 14 of 14 sites. 14 of the 14 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07798648. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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