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

BioNTech

Status and phase: Completed; Phase 3

Conditions: COVID-19; Influenza

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06178991

NCT06178991 (Registry Identifier)

C5261002

Details and patient eligibility

About

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.

Enrollment: 8,798 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8,798 participants in 8 patient groups

Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo

Experimental group

Description:

Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo

Treatment:

Biological: Influenza and COVID-19 Combination A

Biological: Placebo

Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Active Comparator group

Description:

Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Treatment:

Biological: Licensed influenza vaccine

Biological: COVID-19 Vaccine

Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo

Experimental group

Description:

Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo

Treatment:

Biological: Influenza and COVID-19 Combination B

Biological: Placebo

Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Active Comparator group

Description:

Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Treatment:

Biological: Licensed influenza vaccine

Biological: COVID-19 Vaccine

Cohort 3 Arm E:Influenza and COVID-19 Combination B

Experimental group

Description:

Cohort 3 Arm E:Influenza and COVID-19 Combination B

Treatment:

Biological: Influenza and COVID-19 Combination B

Cohort 3 Arm F: COVID-19 vaccine

Active Comparator group

Description:

Cohort 3 Arm F: COVID-19 vaccine

Treatment:

Biological: COVID-19 Vaccine

Cohort 3 Arm G: Licensed influenza vaccine

Active Comparator group

Description:

Cohort 3 Arm G: Licensed influenza vaccine

Treatment:

Biological: Licensed influenza vaccine

Cohort 3 Arm H: Investigational influenza vaccine

Active Comparator group

Description:

Cohort 3 Arm H: Investigational influenza vaccine

Treatment:

Biological: Investigational influenza vaccine