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

NCT ID: NCT06683352

Last Updated: 2025-08-15

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2025-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza,Human COVID-19

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 A

COVID-19 Vaccine (Dose 1) and Placebo

Group Type EXPERIMENTAL

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm B

COVID-19 Vaccine (Dose 2) and Placebo

Group Type EXPERIMENTAL

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm C

COVID-19 Vaccine (Dose 3) and Placebo

Group Type ACTIVE_COMPARATOR

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm D

Investigational Influenza Vaccine (Dose 1) and Placebo

Group Type EXPERIMENTAL

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

Investigational Influenza Vaccine

Placebo

Intervention Type OTHER

Saline

Arm E

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

Group Type ACTIVE_COMPARATOR

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Licensed Influenza Vaccine 1

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 1

Arm EE

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

Group Type ACTIVE_COMPARATOR

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine

Licensed Influenza Vaccine 2

Intervention Type BIOLOGICAL

Licensed Influenza Vaccine 2

Arm F

Investigational Influenza Vaccine (Dose 2) and Placebo

Group Type EXPERIMENTAL

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

Investigational Influenza Vaccine

Placebo

Intervention Type OTHER

Saline

Arm G

Influenza and COVID Combination Vaccine (Combination 1) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm H

Influenza and COVID Combination Vaccine (Combination 2) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm I

Influenza and COVID Combination Vaccine (Combination 3) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm J

Investigational Influenza Vaccine (Dose 3) and Placebo

Group Type EXPERIMENTAL

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

Investigational Influenza Vaccine

Placebo

Intervention Type OTHER

Saline

Arm K

Influenza and COVID Combination Vaccine (Combination 4) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm L

Influenza and COVID Combination Vaccine (Combination 5) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm M

Influenza and COVID Combination Vaccine (Combination 6) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Arm N

Influenza and COVID Combination Vaccine (Combination 7) and Placebo

Group Type EXPERIMENTAL

Influenza and COVID Combination Vaccine

Intervention Type COMBINATION_PRODUCT

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type OTHER

Saline

Interventions

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Investigational Influenza Vaccine

Investigational Influenza Vaccine

Intervention Type BIOLOGICAL

COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

Intervention Type BIOLOGICAL

Influenza and COVID Combination Vaccine

Combined investigational influenza and Pfizer-BioNTech 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

Placebo

Saline

Intervention Type OTHER

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 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.
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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Orange County Research Center

Lake Forest, 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

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

Headlands Research Orlando

Orlando, 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

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, United States

Site Status

Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center

Springfield, Missouri, United States

Site Status

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Site Status

Las Vegas Clinical Trials

Las Vegas, Nevada, United States

Site Status

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, 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

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5261023

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

Other Identifiers

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C5261023

Identifier Type: -

Identifier Source: org_study_id

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