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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07798648
- Acronym / sponsor ID
- C4591083
- Conditions
- COVID-19 Vaccines
- Keywords
- Pneumonia, Respiratory Tract Infections, Pneumonia,Viral, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 21 Apr 2027 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Group 1: 5-11 Years (with risk factors) | Experimental | Biological: BNT162b2Participants will receive a single injection (age appropriate dose) on Day 1 |
| Cohort 1 Group 3: ≥65 Years | Experimental | Biological: BNT162b2Participants will receive a single injection (age appropriate dose) on Day 1. |
| Cohort 1 Group 2: 12-64 Years (with risk factors) | Experimental | Biological: BNT162b2Participants will receive a single injection (age appropriate dose) on Day 1 |
| Cohort 2 Group 5: 18-64 Years (with risk factors) | Experimental | Biological: BNT162b2Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 |
| Cohort 2 Group 4: 18-64 Years (with risk factors) | Experimental | Biological: BNT162b2Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 |
| Cohort 2 Group 6: 18-64 Years (with risk factors) | Experimental | Biological: BNT162b2Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 |
| Cohort 2 Group 7: ≥65 Years | Experimental | Biological: BNT162b2Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 |
| Cohort 2 Group 8: ≥65 Years | Experimental | Biological: BNT162b2Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 |
| Cohort 2 Group 9: ≥65 Years | Experimental | Biological: BNT162b2Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162b2BNT162b2 vaccine 1 (2026/2027 recommended strain) | Biological | Cohort 1 Group 1: 5-11 Years (with risk factors), Cohort 1 Group 2: 12-64 Years (with risk factors), Cohort 1 Group 3: ≥65 Years, Cohort 2 Group 4: 18-64 Years (with risk factors), Cohort 2 Group 7: ≥65 Years |
| BNT162b2BNT162b2 vaccine 2 | Biological | Cohort 2 Group 5: 18-64 Years (with risk factors), Cohort 2 Group 8: ≥65 Years |
| BNT162b2BNT162b2 vaccine 3 | Biological | Cohort 2 Group 6: 18-64 Years (with risk factors), Cohort 2 Group 9: ≥65 Years |
Primary outcome
Percentage of participants reporting local reactions or systemic events
Time frame: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time frame: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Time frame: Through 6 months after vaccination
Geometric Mean Fold Rise (GMFRs)
Time frame: From baseline to 1 month after vaccination
2 secondary outcomes
Geometric Mean Titers (GMTs)
Time frame: At baseline and at 1 month after vaccination
Percentage of participants with seroresponse
Time frame: At 1 month after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNT162b2 in people with COVID-19 Vaccines, run by BioNTech SE at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting local reactions or systemic events (time frame: For up to 7 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.