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

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza, COVID-19

In brief

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.

Key facts

Study ID

NCT06178991

Run by

BioNTech SE

People needed

8795

Starts

2023-12-20

Expected to finish

2024-11-26

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

You may not qualify if…

• Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
• Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration.
• Please refer to the study contact for further eligibility details

Where it is running

• Accel Research Sites - Birmingham Clinical Research Unit — Birmingham, Alabama, United States
• AMR Clinical — Mobile, Alabama, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Foothills Research Center/ CCT Research — Phoenix, Arizona, United States
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States
• Alliance for Multispecialty Research, LLC — Tempe, Arizona, United States
• Baptist Health Center For Clinical Research — Little Rock, Arkansas, United States
• Hope Clinical Research, Inc. — Canoga Park, California, United States
• Ascada Health PC dba Ascada Research — Fullerton, California, United States
• Orange County Research Center — Lake Forest, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Acclaim Clinical Research — San Diego, California, United States
• Bayview Research Group, LLC — Valley Village, California, United States
• Synexus Clinical Research US, Inc. — Vista, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• Universal Axon Clinical Research, LLC — Doral, Florida, 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
• Best Quality Research,Inc. — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• North Alabama Research Center — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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