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

Phase 3

Completed

• Conditions: Influenza; COVID-19
• Interventions: Biological: Licensed influenza vaccine; Biological: COVID-19 Vaccine; Biological: Influenza and COVID-19 Combination A; Biological: Influenza and COVID-19 Combination B; Biological: Investigational influenza vaccine; Biological: Placebo

• Registration Number: NCT06178991
• Lead Sponsor: BioNTech SE

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-20
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2023-12-21
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8798

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group	Licensed influenza vaccine	Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 3 Arm F: COVID-19 vaccine	COVID-19 Vaccine	Cohort 3 Arm F: COVID-19 vaccine
Cohort 3 Arm G: Licensed influenza vaccine	Licensed influenza vaccine	Cohort 3 Arm G: Licensed influenza vaccine
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo	Influenza and COVID-19 Combination A	Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo	Placebo	Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo	Influenza and COVID-19 Combination B	Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo	Placebo	Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Cohort 3 Arm E:Influenza and COVID-19 Combination B	Influenza and COVID-19 Combination B	Cohort 3 Arm E:Influenza and COVID-19 Combination B
Cohort 3 Arm H: Investigational influenza vaccine	Investigational influenza vaccine	Cohort 3 Arm H: Investigational influenza vaccine
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group	COVID-19 Vaccine	Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group	COVID-19 Vaccine	Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group	Licensed influenza vaccine	Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration	4 weeks after vaccination	Describe AEs occurring through 4 weeks following administration of investigational product
GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination	4 weeks after vaccination
GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination	4 weeks after vaccination
The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients	4 weeks after vaccination
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration	Day 7	Describe prompted systemic events following investigational product administration
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration	6 months after vaccination	Describe SAEs through 6 months following administration of investigational product
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration	Day 7	Describe prompted local reactions following investigational product administration
The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19	4 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine alone	4 weeks after vaccination
GMR of SARS-CoV-2-neutralizing titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received COVID-19 vaccine alone	4 weeks after vaccination
GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received investigational influenza vaccine alone	4 weeks after vaccination
GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine concomitantly with COVID-19 vaccine	4 weeks after vaccination
Difference in percentage of participants with seroconversion at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to licensed influenza vaccine administered concomitantly with COVID-19 vaccine recipients	4 weeks after vaccination

Trial Locations

Locations (144)

Velocity Clinical Research, Cincinnati, Mt. Auburn; 🇺🇸 Cincinnati, Ohio, United States

North Alabama Research Center; 🇺🇸 Athens, Alabama, United States

Accel Research Sites - Birmingham Clinical Research Unit; 🇺🇸 Birmingham, Alabama, United States

Medical Affiliated Research Center; 🇺🇸 Huntsville, Alabama, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norfolk, Virginia, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

The Pain Center of Arizona; 🇺🇸 Phoenix, Arizona, 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

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