NCT06178991

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

A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,795 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance. Cohort 1: Approximately 450 participants will be assigned by chance to one of the following: * Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm. * Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm. Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following: * Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm. * Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm. Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following: * Group E: Influenza and COVID-19 combination B vaccine. * Group F: COVID-19 vaccine. * Group G: Licenced influenza vaccine. * Group H: Investigational influenza vaccine. All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.

Conditions

• Influenza
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Influenza and COVID-19 Combination A	Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
BIOLOGICAL	Licensed influenza vaccine	Licensed influenza vaccine
BIOLOGICAL	COVID-19 Vaccine	Pfizer-BioNTech COVID-19 vaccine
BIOLOGICAL	Influenza and COVID-19 Combination B	Combined influenza and Pfizer-BioNTech COVID-19 vaccine
BIOLOGICAL	Placebo	Saline Solution
BIOLOGICAL	Investigational influenza vaccine	Investigational influenza vaccine

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2023-12-21
• Last updated: 2025-12-04
• Results posted: 2025-12-04

Locations

106 sites across 1 country: United States

Regulatory

• FDA-regulated drug study