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

Phase 1

Recruiting

• Conditions: Influenza; COVID-19 (Coronavirus Disease 2019)
• Interventions: Biological: Investigational COVID-19 Vaccine; Combination Product: Investigational Influenza and COVID-19 Combination Vaccine; Biological: Licensed COVID-19 Vaccine; Biological: Licensed Influenza Vaccine 3; Biological: Licensed Influenza Vaccine 1; Biological: Licensed Influenza Vaccine 2; Biological: Investigational Influenza Vaccine

• Registration Number: NCT06821061
• Lead Sponsor: BioNTech SE

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study Start: 2025-02-10
• Study First Posted: 2025-02-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-12-22
• Study Completion: 2025-12-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2645

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Investigational COVID-19 Vaccine	Low Dose COVID-19 Vaccine (1a)
Arm D	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)
Arm E	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Arm H	Licensed COVID-19 Vaccine	Licensed COVID-19 Vaccine
Arm EE	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Arm GG	Licensed Influenza Vaccine 3	Licensed Influenza Vaccine (3)
Arm B	Investigational COVID-19 Vaccine	Low Dose COVID-19 Vaccine ( 1b)
Arm I	Licensed Influenza Vaccine 1	Licensed Influenza Vaccine (1)
Arm J	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
Arm C	Investigational COVID-19 Vaccine	Low Dose COVID-19 Vaccine ( 1c)
Arm F	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Arm K	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
Arm L	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Arm AA	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
Arm CC	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Arm FF	Licensed COVID-19 Vaccine	Licensed COVID-19 Vaccine
Arm G	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Arm M	Licensed COVID-19 Vaccine	Licensed COVID-19 Vaccine
Arm N	Licensed Influenza Vaccine 2	Licensed Influenza Vaccine (2)
Arm DD	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Arm HH	Licensed Influenza Vaccine 2	Licensed Influenza Vaccine (2)
Arm BB	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Arm II	Investigational COVID-19 Vaccine	Low Dose COVID-19 Vaccine ( 1b)
Arm JJ	Investigational COVID-19 Vaccine	Low Dose COVID-19 Vaccine ( 1c)
Arm KK	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Arm LL	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Arm MM	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Arm NN	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Arm OO	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
Arm PP	Investigational Influenza Vaccine	Medium Dose Investigational Influenza Vaccine (1)
Arm QQ	Investigational Influenza Vaccine	High Dose Investigational Influenza Vaccine (2)
Arm RR	Licensed COVID-19 Vaccine	Licensed COVID-19 Vaccine
Arm SS	Licensed Influenza Vaccine 3	Licensed Influenza Vaccine (3)

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration	Day 7
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration	Day 7
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration	1 month
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration	6 months

Secondary Outcome Measures

Name	Time	Method
GMTs before and through 1 month following investigational product administration	Before vaccination through to 1 month after vaccination

Trial Locations

Locations (29)

Upstate Global Health Institute; 🇺🇸 East Syracuse, New York, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

AMR Clinical; 🇺🇸 Knoxville, Tennessee, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

DM Clinical Research - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

DM Clinical Research- Cyfair; 🇺🇸 Houston, Texas, United States

SMS Clinical Research; 🇺🇸 Mesquite, Texas, United States

Clinical Research Consulting; 🇺🇸 Milford, Connecticut, United States

Clinical Research Professionals; 🇺🇸 Chesterfield, Missouri, United States

Clinical Research Associates Inc; 🇺🇸 Nashville, Tennessee, United States

Kaiser Permanente Washington Health Research Institute (KPWHRI); 🇺🇸 Seattle, Washington, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Coral Gables, Florida, United States

Palm Springs Community Health Center; 🇺🇸 Miami Lakes, Florida, United States

J. Lewis Research, Inc. / Foothill Family Clinic South; 🇺🇸 Salt Lake City, Utah, United States

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

Orange County Research Center; 🇺🇸 Lake Forest, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Miami Dade Medical Research Institute, LLC; 🇺🇸 Miami, Florida, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

Las Vegas Clinical Trials; 🇺🇸 North Las Vegas, Nevada, United States

Coastal Carolina Research Center; 🇺🇸 North Charleston, South Carolina, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research; 🇺🇸 Tomball, Texas, United States

Indago Research & Health Center, Inc; 🇺🇸 Hialeah, Florida, United States

Clinical Research Atlanta; 🇺🇸 Stockbridge, Georgia, United States

Trial Management Associates - Wilmington - Floral Parkway; 🇺🇸 Wilmington, North Carolina, United States

Centricity Research Columbus Ohio Multispecialty; 🇺🇸 Columbus, Ohio, United States

Headlands Horizons, LLC dba Headlands Research-Brownsville; 🇺🇸 Brownsville, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic; 🇺🇸 Salt Lake City, Utah, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States