Clinical Trials Directory

Trials / Completed

CompletedNCT05596734

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza

A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
1,019 (actual)
Sponsor
BioNTech SE · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
BIOLOGICALbivalent BNT162b2 (original/Omi BA.4/BA.5)Intramuscular injection
BIOLOGICALqIRV (22/23)Intramuscular injection
BIOLOGICALQIVIntramuscular injection
BIOLOGICALbIRVIntramuscular injection
BIOLOGICALtIRVIntramuscular injection

Timeline

Start date
2022-10-28
Primary completion
2023-12-28
Completion
2023-12-28
First posted
2022-10-27
Last updated
2025-07-23
Results posted
2025-07-23

Locations

59 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05596734. Inclusion in this directory is not an endorsement.