NCT06237049

A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults

A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA COVID-19 Vaccine and a Recombinant Influenza Vaccine Administered as a Single Injection in Healthy Adults 50 Years of Age or Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to see if combining a licensed COVID-19 vaccine and a licensed influenza vaccine into a single shot is safe and can help produce antibodies to defend the body against both SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants enrolled in this trial will be healthy adults, 50 years of age or older.

Detailed description

This is a Phase 1/2 study to evaluate the safety, tolerability, and immunogenicity of licensed BNT162b2 (Omi XBB.1.5) and recombinant influenza vaccine (RIV) administered together as a single injection (referred to as BNT162b2 \[Omi XBB.1.5\]/RIV) in healthy adults 50 years of age or older. The safety, tolerability, and immunogenicity of BNT162b2 (OmiXBB1.5)/RIV administered as a single injection will be compared to BNT162b2 (Omi XBB.1.5) and RIV administered simultaneously as 2 separate injections (coadministered), and to BNT162b2 (Omi XBB.1.5) or RIV when administered alone. Across Phases 1 and 2, approximately 640 participants in total will be randomized with an equal randomization ratio to 1 of 4 vaccine groups and stratified by age.

Conditions

• Influenza, Human
• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 (Omi XBB.1.5)/RIV	Combination of BNT162b2 (Omi XBB.1.5) and RIV
BIOLOGICAL	BNT162b2 (Omi XBB.1.5)	Licensed COVID-19 vaccine
BIOLOGICAL	RIV	Licensed recombinant influenza vaccine
OTHER	Normal saline placebo	Normal saline (solution for injection)

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2024-02-01
• Last updated: 2025-09-30
• Results posted: 2025-09-30

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study