A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
← catalyst calendarSponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Pfizer.
Phase
Phase 1
Status
Withdrawn
Study type
Interventional
Design
Non randomized · None · Prevention
Enrollment
0actual
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
Why the sponsor stopped it
Bivalent vaccine no longer epidemiologically relevant.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-06 | estimated | When the study began enrolling |
| Primary completion | 2026-07-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-13 | estimated | The whole study's end, after follow-up |
| First posted | 2022-11-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- COVID-19
Interventions
- Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
- Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
- Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose
Primary outcomes
what the primary-completion date above is the date OFSubstudy A - Percentage of participants reporting local reactions in each dose level
measured For 7 days following Dose 1, Dose 2, Dose 3
Substudy A - Percentage of participants reporting systemic events in each dose level
measured For 7 days following Dose 1, Dose 2 and Dose 3
Substudy A - Percentage of participants reporting adverse events in each dose level
measured Dose 1 through 1 month after Dose 3
Substudy A - Percentage of participants reporting serious adverse events in each dose level
measured Dose 1 through 6 months after Dose 3
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