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

NCT06821061 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: C6271001C6271001-C1C6271001-C1A
• Study Type: interventional
• Target: 2,650
• Locations: 1 country
• Sites: 31

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.

Conditions

Influenza; COVID-19 (Coronavirus Disease 2019)

Outcome Measures

Primary Outcomes (4)

• Percentage of participants reporting prompted local reactions within 7 days following investigational product administration

  Day 7

• Percentage of participants reporting prompted systemic events 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 Outcomes (1)

• GMTs before and through 1 month following investigational product administration

  Before vaccination through to 1 month after vaccination

Study Arms (33)

Arm A

EXPERIMENTAL

Low Dose COVID-19 Vaccine (1a)

Biological: Investigational COVID-19 Vaccine

Arm B

EXPERIMENTAL

Low Dose COVID-19 Vaccine ( 1b)

Biological: Investigational COVID-19 Vaccine

Arm C

EXPERIMENTAL

Low Dose COVID-19 Vaccine ( 1c)

Biological: Investigational COVID-19 Vaccine

Arm D

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm E

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm F

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm G

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm H

ACTIVE COMPARATOR

Licensed COVID-19 Vaccine

Biological: Licensed COVID-19 Vaccine

Arm I

ACTIVE COMPARATOR

Licensed Influenza Vaccine (1)

Biological: Licensed Influenza Vaccine 1

Arm J

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm K

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm L

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm M

ACTIVE COMPARATOR

Licensed COVID-19 Vaccine

Biological: Licensed COVID-19 Vaccine

Arm N

ACTIVE COMPARATOR

Licensed Influenza Vaccine (2)

Biological: Licensed Influenza Vaccine 2

Arm AA

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm BB

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm CC

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm DD

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm EE

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm FF

ACTIVE COMPARATOR

Licensed COVID-19 Vaccine

Biological: Licensed COVID-19 Vaccine

Arm GG

ACTIVE COMPARATOR

Licensed Influenza Vaccine (3)

Biological: Licensed Influenza Vaccine 3

Arm HH

ACTIVE COMPARATOR

Licensed Influenza Vaccine (2)

Biological: Licensed Influenza Vaccine 2

Arm II

EXPERIMENTAL

Low Dose COVID-19 Vaccine ( 1b)

Biological: Investigational COVID-19 Vaccine

Arm JJ

EXPERIMENTAL

Low Dose COVID-19 Vaccine ( 1c)

Biological: Investigational COVID-19 Vaccine

Arm KK

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm LL

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm MM

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm NN

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm OO

EXPERIMENTAL

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

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Arm PP

EXPERIMENTAL

Medium Dose Investigational Influenza Vaccine (1)

Biological: Investigational Influenza Vaccine

Arm QQ

EXPERIMENTAL

High Dose Investigational Influenza Vaccine (2)

Biological: Investigational Influenza Vaccine

Arm RR

ACTIVE COMPARATOR

Licensed COVID-19 Vaccine

Biological: Licensed COVID-19 Vaccine

Arm SS

ACTIVE COMPARATOR

Licensed Influenza Vaccine (3)

Biological: Licensed Influenza Vaccine 3

Interventions

Investigational Influenza Vaccine BIOLOGICAL

Investigational Influenza Vaccine

Arm PP; Arm QQ

Investigational COVID-19 Vaccine BIOLOGICAL

Investigational COVID-19 Vaccine

Arm A; Arm B; Arm C; Arm II; Arm JJ

Investigational Influenza and COVID-19 Combination Vaccine COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm AA; Arm BB; Arm CC; Arm D; Arm DD; Arm E; Arm EE; Arm F; Arm G; Arm J; Arm K; Arm KK; Arm L; Arm LL; Arm MM; Arm NN; Arm OO

Licensed Influenza Vaccine 1 BIOLOGICAL

Licensed Influenza Vaccine 1

Arm I

Licensed Influenza Vaccine 2 BIOLOGICAL

Licensed Influenza Vaccine 2

Arm HH; Arm N

Licensed Influenza Vaccine 3 BIOLOGICAL

Licensed Influenza Vaccine 3

Arm GG; Arm SS

Licensed COVID-19 Vaccine BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Arm FF; Arm H; Arm M; Arm RR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 18 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (31)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Alliance for Multispecialty Research, LLC

Doral, Florida, 33172, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Upstate Global Health Institute

East Syracuse, New York, 13057, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, 28403, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

AMR Clinical

Knoxville, Tennessee, 37909, United States

Location

AMR Clinical

Knoxville, Tennessee, 37920, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, 78526, United States

Location

DM Clinical Research- Cyfair

Houston, Texas, 77065, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Kaiser Permanente Washington Health Research Institute (KPWHRI)

Seattle, Washington, 98101, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 11, 2025
• Study Start: February 10, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)