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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)
Masking Description
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo 		Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
  • Biological: Influenza and COVID-19 Combination A
    Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
  • Biological: Placebo
    Saline Solution
Active Comparator
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group 		Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
  • Biological: Licensed influenza vaccine
    Licensed influenza vaccine
  • Biological: COVID-19 Vaccine
    Pfizer-BioNTech COVID-19 vaccine
Experimental
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo 		Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
  • Biological: Influenza and COVID-19 Combination B
    Combined influenza and Pfizer-BioNTech COVID-19 vaccine
  • Biological: Placebo
    Saline Solution
Active Comparator
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group 		Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
  • Biological: Licensed influenza vaccine
    Licensed influenza vaccine
  • Biological: COVID-19 Vaccine
    Pfizer-BioNTech COVID-19 vaccine
Experimental
Cohort 3 Arm E:Influenza and COVID-19 Combination B 		Cohort 3 Arm E:Influenza and COVID-19 Combination B
  • Biological: Influenza and COVID-19 Combination B
    Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Active Comparator
Cohort 3 Arm F: COVID-19 vaccine 		Cohort 3 Arm F: COVID-19 vaccine
  • Biological: COVID-19 Vaccine
    Pfizer-BioNTech COVID-19 vaccine
Active Comparator
Cohort 3 Arm G: Licensed influenza vaccine 		Cohort 3 Arm G: Licensed influenza vaccine
  • Biological: Licensed influenza vaccine
    Licensed influenza vaccine
Active Comparator
Cohort 3 Arm H: Investigational influenza vaccine 		Cohort 3 Arm H: Investigational influenza vaccine
  • Biological: Investigational influenza vaccine
    Investigational influenza vaccine

Recruiting Locations

More Details

NCT ID
NCT06178991
Status
Completed
Sponsor
BioNTech SE