A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
← catalyst calendarSponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Pfizer.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
1,353actual
Sites
22
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 | 2024-11-11 | actual | When the study began enrolling |
| Primary completion | 2025-07-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-15 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-12 | actual | When this record first appeared on the registry |
| Results posted | 2026-08-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Influenza,Human
- COVID-19
Interventions
- Biological: Investigational Influenza Vaccine
- Biological: COVID-19 Vaccine
- Combination product: Investigational Influenza/COVID-19 Vaccine
- Biological: Licensed Influenza Vaccine 1
- Biological: Licensed Influenza Vaccine 2
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFCohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
measured From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
measured From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
measured From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
measured From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
measured From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
measured From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
measured From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
measured From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-10-13 · 12.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-11-06 · 3.9 MB · SAP_001.pdf
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