A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

BioNTech

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: COVID-19; Influenza,Human

Treatments: Biological: Investigational Influenza Vaccine; Other: Placebo; Biological: Licensed Influenza Vaccine 1; Biological: COVID-19 Vaccine; Combination Product: Influenza and COVID Combination Vaccine; Biological: Licensed Influenza Vaccine 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06683352

C5261023

Details and patient eligibility

About

This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.

Enrollment: 1,350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants 18 years of age or older
• Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion criteria

• Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine.
• Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1

Please refer to the study contact for further eligibility details.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,350 participants in 15 patient groups

Arm A

Experimental group

Description:

COVID-19 Vaccine (Dose 1) and Placebo

Treatment:

Biological: COVID-19 Vaccine

Other: Placebo

Arm B

Experimental group

Description:

COVID-19 Vaccine (Dose 2) and Placebo

Treatment:

Biological: COVID-19 Vaccine

Other: Placebo

Arm C

Active Comparator group

Description:

COVID-19 Vaccine (Dose 3) and Placebo

Treatment:

Biological: COVID-19 Vaccine

Other: Placebo

Arm D

Experimental group

Description:

Investigational Influenza Vaccine (Dose 1) and Placebo

Treatment:

Other: Placebo

Biological: Investigational Influenza Vaccine

Arm E

Active Comparator group

Description:

Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)

Treatment:

Biological: COVID-19 Vaccine

Biological: Licensed Influenza Vaccine 1

Arm EE

Active Comparator group

Description:

Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)

Treatment:

Biological: Licensed Influenza Vaccine 2

Biological: COVID-19 Vaccine

Arm F

Experimental group

Description:

Investigational Influenza Vaccine (Dose 2) and Placebo

Treatment:

Other: Placebo

Biological: Investigational Influenza Vaccine

Arm G

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 1) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo

Arm H

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 2) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo

Arm I

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 3) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo

Arm J

Experimental group

Description:

Investigational Influenza Vaccine (Dose 3) and Placebo

Treatment:

Other: Placebo

Biological: Investigational Influenza Vaccine

Arm K

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 4) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo

Arm L

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 5) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo

Arm M

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 6) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo

Arm N

Experimental group

Description:

Influenza and COVID Combination Vaccine (Combination 7) and Placebo

Treatment:

Combination Product: Influenza and COVID Combination Vaccine

Other: Placebo