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
← 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
774actual
Sites
19
Country
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 | 2025-07-08 | actual | When the study began enrolling |
| Primary completion | 2026-05-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-01 | actual | The whole study's end, after follow-up |
| First posted | 2025-07-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-01 | 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 recommended SARS-CoV-2 strain)
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
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
Publications
- PMID 42042826 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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