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
Arm | Description | Assigned 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 |
|
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 |
|
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 |
|
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 |
|
Experimental Cohort 3 Arm E:Influenza and COVID-19 Combination B |
Cohort 3 Arm E:Influenza and COVID-19 Combination B |
|
Active Comparator Cohort 3 Arm F: COVID-19 vaccine |
Cohort 3 Arm F: COVID-19 vaccine |
|
Active Comparator Cohort 3 Arm G: Licensed influenza vaccine |
Cohort 3 Arm G: Licensed influenza vaccine |
|
Active Comparator Cohort 3 Arm H: Investigational influenza vaccine |
Cohort 3 Arm H: Investigational influenza vaccine |
|
Recruiting Locations
More Details
- NCT ID
- NCT06178991
- Status
- Completed
- Sponsor
- BioNTech SE