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Study identifier: NCT06178991 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Completed

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

Condition: Influenza · COVID-19  ·  Sponsor: BioNTech SE

PhasePhase 3
Planned participants8795
Who can joinAll sexes, 18 Years to 64 Years
Healthy volunteersYes

About this study

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 …

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (106)

North Alabama Research CenterAthens, Alabama, United States
Accel Research Sites - Birmingham Clinical Research UnitBirmingham, Alabama, United States
AMR ClinicalMobile, Alabama, United States
HOPE Research InstitutePhoenix, Arizona, United States
Foothills Research Center/ CCT ResearchPhoenix, Arizona, United States
Scottsdale Clinical TrialsScottsdale, Arizona, United States
Alliance for Multispecialty Research, LLCTempe, Arizona, United States
Baptist Health Center For Clinical ResearchLittle Rock, Arkansas, United States
Hope Clinical Research, Inc.Canoga Park, California, United States
Ascada Health PC dba Ascada ResearchFullerton, California, United States
Orange County Research CenterLake Forest, California, United States
Ark Clinical ResearchLong Beach, California, United States

+ 94 more locations — full list on the registry record.

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