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

Trial status:Study Complete
Trial ID:
C5261002
NCT ID:
NCT06178991
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Study Complete

Results available

Study Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Trial Details

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.

Medical Condition
Influenza
COVID-19
Study Drug
Influenza and COVID-19 Combination A
See more
Licensed influenza vaccine
COVID-19 Vaccine
Influenza and COVID-19 Combination B
Placebo
Investigational influenza vaccine
Phase
Phase 3
Type
Interventional
Estimated Enrolment
8795
Estimated Trial Date
Dec 2023 - Nov 2024

Trial Participant Requirements

Age
18 - 64 Years
Sex
Female & Male
Healthy Volunteers
Yes
Inclusion and Exclusion Criteria
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

Trial Locations

Location
Status
Location
North Alabama Research Center
Athens, Alabama, United States, 35611
Status
Location
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35216
Status
Location
AMR Clinical
Mobile, Alabama, United States, 36608
Status
Location
HOPE Research Institute
Phoenix, Arizona, United States, 85032
Status
Location
Foothills Research Center/ CCT Research
Phoenix, Arizona, United States, 85044
Status
Location
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
Status
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