A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Phase 2
Completed
NCT05596734
| Condition | Influenza, Human, COVID-19 |
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| Phase | Phase 2 |
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| Sponsor | BioNTech SE |
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| Status | Completed |
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| Enrollment | 1,019 participants |
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| Interventions | bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV, bIRV, tIRV |
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| Start date | Oct 28, 2022 |
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| Completion date | Dec 28, 2023 |
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| Results posted | Jul 23, 2025 |
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Summary
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: * qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations * qIRV (22/23) at dose level 1, * qIRV (22/23) at dose level 2, or * bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)
SSA: From Day 1 to Day 7 after Vaccination · Percentage of participants
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 83.3 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 89.3 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 80.0 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV 30 mcg | 63.3 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV 60 mcg | 73.3 Percentage of participants |
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| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 71.9 Percentage of participants |
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SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years)
SSA: From Day 1 to Day 7 after Vaccination · Percentage of participants
| Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 84.8 Percentage of participants |
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| Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg | 53.1 Percentage of participants |
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| Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 84.8 Percentage of participants |
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| Substudy A, >=65 Years: qIRV 30 mcg | 63.6 Percentage of participants |
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| Substudy A, >=65 Years: qIRV 60 mcg | 72.7 Percentage of participants |
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| Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV | 51.5 Percentage of participants |
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SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years)
SSA: From Day 1 to Day 7 after Vaccination · Percentage of participants
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 76.7 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 78.6 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 70.0 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV 30 mcg | 53.3 Percentage of participants |
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| Substudy A, 18-64 Years: qIRV 60 mcg | 63.3 Percentage of participants |
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| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 68.8 Percentage of participants |
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