A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through… (NCT07222384) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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
United States, Puerto Rico343 participantsStarted 2025-10-30
Plain-language 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 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.
Who can participate
Age range
5 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants reporting local reactions
Timeframe: For up to 7 days after vaccination
2
Percentage of participants reporting systemic events
Timeframe: For up to 7 days after vaccination
3
Percentage of participants reporting adverse events
Timeframe: Through 1 month after vaccination
4
Percentage of participants reporting serious adverse events
Timeframe: Through 6 months after vaccination
5
Geometric Mean Fold Rises (GMFRs)
Timeframe: From before vaccination to 1 month after vaccination