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

NCT ID: NCT06821061

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2645 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-12-22

Brief Summary

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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

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Conditions

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Influenza COVID-19 (Coronavirus Disease 2019)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm OO

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm PP

Medium Dose Investigational Influenza Vaccine (1)

Group Type EXPERIMENTAL

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

Investigational Influenza Vaccine

Arm QQ

High Dose Investigational Influenza Vaccine (2)

Group Type EXPERIMENTAL

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

Investigational Influenza Vaccine

Arm RR

Licensed COVID-19 Vaccine

Group Type ACTIVE_COMPARATOR

Licensed COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Arm SS

Licensed Influenza Vaccine (3)

Group Type ACTIVE_COMPARATOR

Licensed Influenza Vaccine 3

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 3

Arm A

Low Dose COVID-19 Vaccine (1a)

Group Type EXPERIMENTAL

Investigational COVID-19 Vaccine

Intervention Type BIOLOGICAL

Investigational COVID-19 Vaccine

Arm B

Low Dose COVID-19 Vaccine ( 1b)

Group Type EXPERIMENTAL

Investigational COVID-19 Vaccine

Intervention Type BIOLOGICAL

Investigational COVID-19 Vaccine

Arm C

Low Dose COVID-19 Vaccine ( 1c)

Group Type EXPERIMENTAL

Investigational COVID-19 Vaccine

Intervention Type BIOLOGICAL

Investigational COVID-19 Vaccine

Arm D

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm E

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm F

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm G

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm H

Licensed COVID-19 Vaccine

Group Type ACTIVE_COMPARATOR

Licensed COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Arm I

Licensed Influenza Vaccine (1)

Group Type ACTIVE_COMPARATOR

Licensed Influenza Vaccine 1

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 1

Arm J

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm K

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm L

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm M

Licensed COVID-19 Vaccine

Group Type ACTIVE_COMPARATOR

Licensed COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Arm N

Licensed Influenza Vaccine (2)

Group Type ACTIVE_COMPARATOR

Licensed Influenza Vaccine 2

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 2

Arm AA

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm BB

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm CC

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm DD

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm EE

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm FF

Licensed COVID-19 Vaccine

Group Type ACTIVE_COMPARATOR

Licensed COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Arm GG

Licensed Influenza Vaccine (3)

Group Type ACTIVE_COMPARATOR

Licensed Influenza Vaccine 3

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 3

Arm HH

Licensed Influenza Vaccine (2)

Group Type ACTIVE_COMPARATOR

Licensed Influenza Vaccine 2

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 2

Arm II

Low Dose COVID-19 Vaccine ( 1b)

Group Type EXPERIMENTAL

Investigational COVID-19 Vaccine

Intervention Type BIOLOGICAL

Investigational COVID-19 Vaccine

Arm JJ

Low Dose COVID-19 Vaccine ( 1c)

Group Type EXPERIMENTAL

Investigational COVID-19 Vaccine

Intervention Type BIOLOGICAL

Investigational COVID-19 Vaccine

Arm KK

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm LL

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm MM

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Arm NN

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

Group Type EXPERIMENTAL

Investigational Influenza and COVID-19 Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Interventions

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Investigational Influenza Vaccine

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

Investigational COVID-19 Vaccine

Investigational COVID-19 Vaccine

Intervention Type BIOLOGICAL

Investigational Influenza and COVID-19 Combination Vaccine

Investigational Combined Influenza and COVID-19 Vaccine

Intervention Type COMBINATION_PRODUCT

Licensed Influenza Vaccine 1

Licensed Influenza Vaccine 1

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 2

Licensed Influenza Vaccine 2

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 3

Licensed Influenza Vaccine 3

Intervention Type BIOLOGICAL

Licensed COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

BioNTech SE

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Orange County Research Center

Lake Forest, California, United States

Site Status

Artemis Institute for Clinical Research

Riverside, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Clinical Research Consulting

Milford, Connecticut, United States

Site Status

Alliance for Multispecialty Research, LLC

Doral, Florida, United States

Site Status

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Site Status

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Site Status

Clinical Research Atlanta

Stockbridge, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Site Status

Upstate Global Health Institute

East Syracuse, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States

Site Status

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Site Status

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Site Status

AMR Clinical

Knoxville, Tennessee, United States

Site Status

AMR Clinical

Knoxville, Tennessee, United States

Site Status

Clinical Research Associates Inc

Nashville, Tennessee, United States

Site Status

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, United States

Site Status

DM Clinical Research- Cyfair

Houston, Texas, United States

Site Status

SMS Clinical Research

Mesquite, Texas, United States

Site Status

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

Tomball, Texas, United States

Site Status

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

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

Salt Lake City, Utah, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Kaiser Permanente Washington Health Research Institute (KPWHRI)

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C6271001

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

Other Identifiers

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C6271001

Identifier Type: -

Identifier Source: org_study_id