COVID-19 VaccinesPhase 3NCT07798648
A Study of COVID-19 Vaccine(s) in Children and Adults
A Phase 3 study testing BNT162b2 in people with COVID-19 Vaccines, run by BioNTech SE at 14 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- BNT162b2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 14 sitesUnited States
- Study dates
- 31 Aug 2026to 21 Apr 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
AGILE Clinical Research Trials, LLC
Atlanta, Georgia, 30328
- Recruiting
Kentucky Pediatric /Adult Research
Bardstown, Kentucky, 40004
- Recruiting
Cedar Health Research
Dallas, Texas, 75251
- Recruiting
Dayton Clinical Research
Dayton, Ohio, 45409
- Recruiting
Cedar Health Research
Euless, Texas, 76040
- Recruiting
C & R Research Servcies USA, Inc.
Homestead, Florida, 33030
- Recruiting
East-West Medical Research Institute
Honolulu, Hawaii, 96814
- Recruiting
DM Clinical Research-Cyfair
Houston, Texas, 77065
- Recruiting
Indago Research & Health Center, Inc
Miami Lakes, Florida, 33016
- Recruiting
DM Clinical Research
Philadelphia, Pennsylvania, 19107
- 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
Senders Pediatrics
South Euclid, Ohio, 44121
- Recruiting
DM Clinical Research
Tomball, Texas, 77375
About this study
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
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:
Read more
- 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.
- Conditions
- COVID-19 Vaccines
- Being tested
- BNT162b2
- Keywords
- Pneumonia, Respiratory Tract Infections, Pneumonia,Viral, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19, mRNA Vaccines, Nucleic Acid-Based Vaccine, Vaccines, Synthetic, Recombinant Proteins, Proteins, Amino Acids, Peptides, and Proteins, Vaccines, Biological Products
- Medical subject headings
- Pneumonia, Respiratory Tract Infections, Pneumonia, Viral, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2Biological
BNT162b2 vaccine 1 (2026/2027 recommended strain)
BNT162b2Biological
BNT162b2 vaccine 2
BNT162b2Biological
BNT162b2 vaccine 3
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Group 1: 5-11 Years (with risk factors) | Experimental | Participants will receive a single injection (age appropriate dose) on Day 1 Receives: Biological: BNT162b2 |
| Cohort 1 Group 3: ≥65 Years | Experimental | Participants will receive a single injection (age appropriate dose) on Day 1. Receives: Biological: BNT162b2 |
| Cohort 1 Group 2: 12-64 Years (with risk factors) | Experimental | Participants will receive a single injection (age appropriate dose) on Day 1 Receives: Biological: BNT162b2 |
| Cohort 2 Group 5: 18-64 Years (with risk factors) | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 Receives: Biological: BNT162b2 |
| Cohort 2 Group 4: 18-64 Years (with risk factors) | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 Receives: Biological: BNT162b2 |
| Cohort 2 Group 6: 18-64 Years (with risk factors) | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 Receives: Biological: BNT162b2 |
| Cohort 2 Group 7: ≥65 Years | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 Receives: Biological: BNT162b2 |
| Cohort 2 Group 8: ≥65 Years | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 Receives: Biological: BNT162b2 |
| Cohort 2 Group 9: ≥65 Years | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 Receives: Biological: BNT162b2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions or systemic events
Measured: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Measured: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Measured: Through 6 months after vaccination
Geometric Mean Fold Rise (GMFRs)
Measured: From baseline to 1 month after vaccination
Secondary outcomes (2)
Geometric Mean Titers (GMTs)
Measured: At baseline and at 1 month after vaccination
Percentage of participants with seroresponse
Measured: At 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start31 Aug 2026
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798648
- Sponsor's protocol ID
- C4591083
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No