A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

BioNTech

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

Conditions: COVID-19 (Coronavirus Disease 2019); Influenza

Treatments: Biological: Licensed Influenza Vaccine 1; Biological: Investigational Influenza Vaccine; Combination Product: Investigational Influenza and COVID-19 Combination Vaccine; Biological: Licensed Influenza Vaccine 2; Biological: Investigational COVID-19 Vaccine; Biological: Licensed COVID-19 Vaccine; Biological: Licensed Influenza Vaccine 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06821061

C6271001

Details and patient eligibility

About

The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.

This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.

Enrollment: 2,050 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 judgement of the investigator to be eligible for inclusion in the study

Exclusion criteria

• Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
• Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
• Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1.

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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2,050 participants in 30 patient groups

Arm A

Experimental group

Description:

Low Dose COVID-19 Vaccine (1a)

Treatment:

Biological: Investigational COVID-19 Vaccine

Arm B

Experimental group

Description:

Low Dose COVID-19 Vaccine ( 1b)

Treatment:

Biological: Investigational COVID-19 Vaccine

Arm C

Experimental group

Description:

Low Dose COVID-19 Vaccine ( 1c)

Treatment:

Biological: Investigational COVID-19 Vaccine

Arm D

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm E

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm F

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm G

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm H

Active Comparator group

Description:

Low Dose Licensed COVID-19 Vaccine

Treatment:

Biological: Licensed COVID-19 Vaccine

Arm I

Active Comparator group

Description:

Licensed Influenza Vaccine (1)

Treatment:

Biological: Licensed Influenza Vaccine 1

Arm AA

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm BB

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm CC

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm DD

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm EE

Active Comparator group

Description:

Low Dose Licensed COVID-19 Vaccine

Treatment:

Biological: Licensed COVID-19 Vaccine

Arm FF

Active Comparator group

Description:

Licensed Influenza Vaccine (2)

Treatment:

Biological: Licensed Influenza Vaccine 2

Arm GG

Experimental group

Description:

Low Dose COVID-19 Vaccine (1a)

Treatment:

Biological: Investigational COVID-19 Vaccine

Arm HH

Experimental group

Description:

Low Dose COVID-19 Vaccine (1b)

Treatment:

Biological: Investigational COVID-19 Vaccine

Arm II

Experimental group

Description:

Low Dose COVID-19 Vaccine (1c)

Treatment:

Biological: Investigational COVID-19 Vaccine

Arm JJ

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 5)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm KK

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm LL

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm MM

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 8)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm NN

Experimental group

Description:

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 9)

Treatment:

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm OO

Experimental group

Description:

Medium Dose Investigational Influenza Vaccine (1a)

Treatment:

Biological: Investigational Influenza Vaccine

Arm PP

Experimental group

Description:

Medium Dose Investigational Influenza Vaccine (1b)

Treatment:

Biological: Investigational Influenza Vaccine

Arm QQ

Experimental group

Description:

Low Dose Investigational Influenza Vaccine (2a)

Treatment:

Biological: Investigational Influenza Vaccine

Arm RR

Experimental group

Description:

Medium Dose Investigational Influenza Vaccine (2b)

Treatment:

Biological: Investigational Influenza Vaccine

Arm SS

Active Comparator group

Description:

Low Dose Licensed COVID-19 Vaccine

Treatment:

Biological: Licensed COVID-19 Vaccine

Arm TT

Active Comparator group

Description:

Licensed Influenza Vaccine (2)

Treatment:

Biological: Licensed Influenza Vaccine 2

Arm UU

Active Comparator group

Description:

Licensed Influenza Vaccine (3)

Treatment:

Biological: Licensed Influenza Vaccine 3