COVID-19Phase 3NCT07222384
A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
A Phase 3 study testing BNT162b2 (2025/2026 formulation) in people with COVID-19 and SARS-COV-2 Infection, run by BioNTech SE at 29 sites in 2 countries.
Trial summary
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 (2025/2026 formulation). This study is seeking participants 5 through 11 years of age who: have at least 1 underlying condition that puts them at high risk for severe… Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-COV-2 Infection
- What is being tested?
- BNT162b2 (2025/2026 formulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 30 Oct 2025to 24 Jul 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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 5 through 11 years of age at their first appointment.
- Children with at least 1 underlying stable medical condition that increases their risk of severe COVID-19, as listed in the protocol.
Who cannot join
- Children who have had confirmed COVID-19 within the last 5 months (150 days).
- Children who have received a COVID-19 vaccine, either as part of a research study or an approved vaccine, within the last 5 months (150 days).
- Children who have received a 2025-2026 seasonal COVID-19 vaccination.
- Children with a history of myocarditis or pericarditis.
- Children with a previous or current diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C)
- Children with a medical condition wherein they would be considered for a second dose of COVID-19 vaccine to protect against risk of severe COVID-19 based on standard of care.
- Refer to the study contact for further eligibility details.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
Medical Research Partners
Ammon, Idaho, 83406
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Michigan Center of Medical Research (MICHMER)
Bingham Farms, Michigan, 48025
Cincinnati Children's Hospital Medical Center- Infectious Disease
Cincinnati, Ohio, 45206
Dayton Clinical Research
Dayton, Ohio, 45409
C & R Research USA
Homestead, Florida, 33030
DM Clinical Research- Cyfair
Houston, Texas, 77065
AMR Clinical
Layton, Utah, 84041
Florida Pharmaceutical Research and Associates
Miami, Florida, 33143
Bio-Medical Research LLC
Miami, Florida, 33144
Indago Research & Health Center, Inc
Miami Lakes, Florida, 33016
Clinical Research Institute
Minneapolis, Minnesota, 55402
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
AMR Clinical
Oak Brook, Illinois, 60523
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Stanford University Medical Center CTRU - 800 Welch Road
Palo Alto, California, 94304
ACRC Trials
Plano, Texas, 75024
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Tekton Research, LLC.
Richmond, Virginia, 23233
University of Rochester Medical Center
Rochester, New York, 14642
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
Sun Research Institute
San Antonio, Texas, 78215
California Research Foundation
San Diego, California, 92123
Senders Pediatrics
South Euclid, Ohio, 44121
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33714
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas, 76401
Puerto Rico2 sites
Clinical Research Puerto Rico
Guayama, Puerto RICO, 00784
Ponce Medical School Foundation Inc.
Ponce, Puerto RICO, 00716
About this study
Official title: A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162B2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 (2025/2026 formulation).
This study is seeking participants 5 through 11 years of age who:
Read more
- have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19,
- and are medically stable.
All participants in this study will receive 1 vaccine dose given in the muscle of their arm of a BNT162b2 (2025/2026 formulation) vaccine which targets the COVID-19 virus, specifically the strain selected for the 2025-2026 COVID-19 viral respiratory season.
Participants will take part in this study for about 6 months and will need to visit the clinical study site at least 2 times.
- Conditions
- COVID-19, SARS-COV-2 Infection
- Being tested
- BNT162b2 (2025/2026 formulation)
- Keywords
- Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19, mRNA Vaccines, Nucleic Acid-Based Vaccines, Vaccines, Biological Products, COVID-19 Vaccines, Viral Vaccines, Antigens, Biological Factors, BNT162 Vaccine
- Medical subject headings
- COVID-19, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 (2025/2026 formulation)Biological
BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)
| Study group | Role | What they receive |
|---|---|---|
| 5-11 Years (Higher-Risk Individuals) | Experimental | BNT162b2 (2025/2026 formulation) Receives: Biological: BNT162b2 (2025/2026 formulation) |
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
Geometric Mean Fold Rises (GMFRs)
Measured: From before vaccination to 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 posted29 Oct 2025
- Study start30 Oct 2025
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 344 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
- NCT07222384
- Sponsor's protocol ID
- C4591082
- Other IDs
- NCT07222384
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2025
- Last updated
- 7 Aug 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 7 Aug 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 A BNT162B2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19
- ClinicalTrials.gov ID
- NCT07222384
- Acronym / sponsor ID
- C4591082
- Conditions
- COVID-19, SARS-COV-2 Infection
- Keywords
- Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 29 Oct 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, called BNT162b2 (2025/2026 formulation).
This study is seeking participants 5 through 11 years of age who:
- have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19,
- and are medically stable.
All participants in this study will receive 1 vaccine dose given in the muscle of their arm of a BNT162b2 (2025/2026 formulation) vaccine which targets the COVID-19 virus, specifically the strain selected for the 2025-2026 COVID-19 viral respiratory season.
Participants will take part in this study for about 6 months and will need to visit the clinical study site at least 2 times.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-11 Years (Higher-Risk Individuals) | Experimental | Biological: BNT162b2 (2025/2026 formulation)BNT162b2 (2025/2026 formulation) |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 5 through 11 years of age at their first appointment.
- Children with at least 1 underlying stable medical condition that increases their risk of severe COVID-19, as listed in the protocol.
Key exclusion criteria (7 listed)
- Children who have had confirmed COVID-19 within the last 5 months (150 days).
- Children who have received a COVID-19 vaccine, either as part of a research study or an approved vaccine, within the last 5 months (150 days).
- Children who have received a 2025-2026 seasonal COVID-19 vaccination.
- Children with a history of myocarditis or pericarditis.
- Children with a previous or current diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C)
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 formulation)BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain) | Biological | 5-11 Years (Higher-Risk Individuals) |
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
Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 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 7 Aug 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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNT162b2 (2025/2026 formulation) in people with COVID-19 and SARS-COV-2 Infection, run by BioNTech SE at 29 sites in 2 countries.
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 7 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. 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 5 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 7 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.