A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
← catalyst calendarSponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Pfizer.
Phase
Phase 2/3
Status
Completed
Study type
Interventional
Design
Na · None · Prevention
Enrollment
1,051actual
Sites
37
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 | 2023-08-10 | actual | When the study began enrolling |
| Primary completion | 2025-03-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-13 | actual | The whole study's end, after follow-up |
| First posted | 2023-08-18 | actual | When this record first appeared on the registry |
| Results posted | 2026-04-28 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- SARS-CoV-2 Infection
- COVID-19
Interventions
- Biological: BNT162b2 (Omi XBB.1.5)
- Biological: BNT162b2 (Omi JN.1)
- Biological: BNT162b2 (Omi KP.2)
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA
measured Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA
measured Day 1 to Day 7 after vaccination
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA
measured From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA
measured From vaccination on Day 1 up to 6 months after vaccination
Geometric Mean Titers (GMT) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
measured At 1 month after vaccination
GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
measured At 1 month after vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Study Vaccination to 1 Month After Vaccination: SSA and Historical Control of Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
measured From before vaccination on Day 1 up to 1 month after vaccination
GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
measured From before vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
measured At 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
measured At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB
measured Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB
measured Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB
measured From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB
measured From vaccination on Day 1 up to 6 months after vaccination
Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine-Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
measured At 1 month after vaccination
Percentage of Participants and Difference in Percentage of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
measured At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
measured Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
measured Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
measured From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
measured From vaccination on Day 1 up to 6 months after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3
measured Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3
measured Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3
measured From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3
measured From vaccination on Day 1 up to 6 months after vaccination
GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
measured At 1 month after vaccination
GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
measured From before Vaccination to 1 month after Vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
measured At 1 month after vaccination
GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and SSC Cohorts 1 + 2 Combined as Control
measured At 1 month after vaccination
GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
measured From before vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
measured At 1 month after vaccination
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-08-07 · 1.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-08-23 · 986 KB · SAP_001.pdf
Publications
- PMID 40591130 — linked by the registry
- PMID 39999538 — linked by the registry
- PMID 39066372 — linked by the registry
- PMID 38400102 — 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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