COVID-19Phase 3NCT07069309
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
A Phase 3 study testing BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) in people with COVID-19 and SARS-COV-2 Infection, run by BioNTech SE at 19 sites in United States.
Trial summary
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19. This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-COV-2 Infection
- What is being tested?
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 19 sitesUnited States
- Study dates
- 8 Jul 2025to 1 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cohort 1: Participants 18 years of age or older.
- Cohort 2: Participants 12 years of age or older.
- Participants 12 through 64 years of age with 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.
- Cohort 2: 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 5 months (150 days) prior to study enrollment.
- Refer to the study contact for further eligibility details.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Charlottesville Medical Research
Charlottesville, Virginia, 22911
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
East-West Medical Research Institute
Honolulu, Hawaii, 96814
DM Clinical Research- Cyfair
Houston, Texas, 77065
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Clinical Research Consulting
Milford, Connecticut, 06460
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
Rochester Clinical Research, LLC
Rochester, New York, 14609
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
Senders Pediatrics
South Euclid, Ohio, 44121
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, 65807
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
GW Vaccine Research Unit
Washington D.C., District of Columbia, 20037
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Accellacare - Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN PARTICIPANTS 12 THROUGH 64 YEARS OF AGE CONSIDERED AT HIGHER RISK OF SEVERE COVID-19, AND PARTICIPANTS ≥65 YEARS OF AGE
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.
- Conditions
- COVID-19, SARS-COV-2 Infection
- Being tested
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)Biological
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 18 through 64 years of age (higher-risk individuals) | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 Receives: Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) |
| Group 2: 65 years of age and older | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 Receives: Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) |
| Group 3: 12 through 64 years of age (higher-risk individuals) | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 Receives: Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) |
| Group 4: 65 years of age and older | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 Receives: Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions
Measured: For up to 7 days after vaccination
Percentage of participants reporting 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
Cohort 1: Geometric Mean Titers (GMTs)
Measured: At 2 weeks after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
Measured: From before vaccination to 2 weeks after vaccination
Cohort 1: Percentages of participants with seroresponse
Measured: 2 weeks after vaccination
Cohort 2: Geometric Mean Fold Rises (GMFRs)
Measured: From before vaccination to 1 month after vaccination
Secondary outcomes (5)
Cohort 1: Geometric Mean Titers (GMTs)
Measured: At 1 month after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
Measured: From before vaccination to 1 month after vaccination
Cohort 1: Percentages of participants with seroresponse
Measured: 1 month after vaccination
Cohort 2: Geometric Mean Titers (GMTs)
Measured: From before vaccination to 1 month after vaccination
Cohort 2: Percentages of participants with seroresponse
Measured: 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 posted16 Jul 2025
- Study start8 Jul 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 774 participants (actual)
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
- NCT07069309
- Sponsor's protocol ID
- C4591076
- Status last verified
- May 2026
- First submitted
- 7 Jul 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dadhe R, Gayed J, Iqbal M, Solan R, Wu H, Ma H, Xu X, Mensa FJ, Belanger T, Cooper D, Mogg R, Anderson AS, Tureci O, Sahin U, Allen PS, Modjarrad K, Gurtman A, Lindert K. A Study to Investigate the Safety and Immunogenicity of Monovalent Omicron LP.8.1-Adapted BNT162b2 COVID-19 Vaccine in Adults >/= 65 Years of Age and High-Risk Adults 18-64 Years of Age (Preliminary Results). Vaccines (Basel). 2026 Apr 15;14(4):350. doi: 10.3390/vaccines14040350.
PubMed 42042826
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN PARTICIPANTS 12 THROUGH 64 YEARS OF AGE CONSIDERED AT HIGHER RISK OF SEVERE COVID-19, AND PARTICIPANTS ≥65 YEARS OF AGE
- ClinicalTrials.gov ID
- NCT07069309
- Acronym / sponsor ID
- C4591076
- Conditions
- COVID-19, SARS-COV-2 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 16 Jul 2025 (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, tolerability, and immunogenicity of an updated vaccine against COVID-19.
This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 18 through 64 years of age (higher-risk individuals) | Experimental | Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
| Group 2: 65 years of age and older | Experimental | Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
| Group 3: 12 through 64 years of age (higher-risk individuals) | Experimental | Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
| Group 4: 65 years of age and older | Experimental | Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cohort 1: Participants 18 years of age or older.
- Cohort 2: Participants 12 years of age or older.
- Participants 12 through 64 years of age with 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.
- Cohort 2: 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 5 months (150 days) prior to study enrollment.
- 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 |
|---|---|---|
| BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain) | Biological | Group 1: 18 through 64 years of age (higher-risk individuals), Group 2: 65 years of age and older, Group 3: 12 through 64 years of age (higher-risk individuals), Group 4: 65 years of age and older |
Primary outcome
Percentage of participants reporting local reactions
Time frame: For up to 7 days after vaccination
Percentage of participants reporting 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
Cohort 1: Geometric Mean Titers (GMTs)
Time frame: At 2 weeks after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 2 weeks after vaccination
Cohort 1: Percentages of participants with seroresponse
Time frame: 2 weeks after vaccination
Cohort 2: Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 1 month after vaccination
5 secondary outcomes
Cohort 1: Geometric Mean Titers (GMTs)
Time frame: At 1 month after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 1 month after vaccination
Cohort 1: Percentages of participants with seroresponse
Time frame: 1 month after vaccination
Cohort 2: Geometric Mean Titers (GMTs)
Time frame: From before vaccination to 1 month after vaccination
Cohort 2: Percentages of participants with seroresponse
Time frame: 1 month after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 42042826Dadhe R, Gayed J, Iqbal M, Solan R, Wu H, Ma H, Xu X, Mensa FJ, Belanger T, Cooper D, Mogg R, Anderson AS, Tureci O, Sahin U, Allen PS, Modjarrad K, Gurtman A, Lindert K. A Study to Investigate the Safety and Immunogenicity of Monovalent Omicron LP.8.1-Adapted BNT162b2 COVID-19 Vaccine in Adults >/= 65 Years of Age and High-Risk Adults 18-64 Years of Age (Preliminary Results). Vaccines (Basel). 2026 Apr 15;14(4):350. doi: 10.3390/vaccines14040350.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COVID-19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
19 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 (2025/2026 recommended SARS-CoV-2 strain) in people with COVID-19 and SARS-COV-2 Infection, run by BioNTech SE at 19 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 3 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: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting local reactions (time frame: For up to 7 days after vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07069309, which also lists 1 linked publication.
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 1 Jun 2026.