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
← catalyst calendarSponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Pfizer.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Prevention
Enrollment
344actual
Sites
29
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-30 | actual | When the study began enrolling |
| Primary completion | 2026-07-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-24 | actual | The whole study's end, after follow-up |
| First posted | 2025-10-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- COVID-19
- SARS-COV-2 Infection
Intervention
- Biological: BNT162b2 (2025/2026 formulation)
Primary outcomes
what the primary-completion date above is the date OFPercentage 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
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