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

Completed · Phase 2

Conditions studied: Influenza, Human, COVID-19

In brief

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).

Key facts

Study ID

NCT05596734

Run by

BioNTech SE

People needed

1019

Starts

2022-10-28

Expected to finish

2023-12-28

Last updated by the study team

2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

Where it is running

• The Heart Center — Athens, Alabama, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Orange County Research Center — Lake Forest, California, United States
• Orange County Heart Institute — Orange, California, United States
• California Research Foundation — San Diego, California, United States
• Orange County Research Center — Tustin, California, United States
• Proactive Clinical Research,LLC — Fort Lauderdale, Florida, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• Research Centers of America ( Hollywood ) — Hollywood, Florida, United States
• Angels Clinical Research Institute — Miami, Florida, United States
• Miami Clinical Research — Miami, Florida, United States
• Gerardo Polanco, MD — Miami, Florida, United States
• Research Institute of South Florida — Miami, Florida, United States
• Entrust Clinical Research — Miami, Florida, United States
• Jackson Medical Group Cardiac Care — Miami, Florida, United States
• Miami Dade Medical Research Institute, LLC — Miami, Florida, United States
• Palm Springs Community Health Center — Miami Lakes, Florida, United States
• Panax Clinical Research — Miami Lakes, Florida, United States
• Palm Springs Community Health Center — Miami Lakes, Florida, United States
• Innovation Medical Research Center — Palmetto Bay, Florida, United States
• DBC Research USA — Pembroke Pines, Florida, United States
• United Medical Research — Port Orange, Florida, United States
• North Alabama Research Center — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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