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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

NCT ID: NCT06178991

Last Updated: 2025-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8795 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-11-26

Brief Summary

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The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.

Cohort 1: Approximately 450 participants will be assigned by chance to one of the following:

* Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm.
* Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm.

Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following:

* Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm.
* Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.

Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:

* Group E: Influenza and COVID-19 combination B vaccine.
* Group F: COVID-19 vaccine.
* Group G: Licenced influenza vaccine.
* Group H: Investigational influenza vaccine.

All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.

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Detailed Description

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Conditions

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Influenza COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.

Study Groups

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Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo

Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo

Group Type EXPERIMENTAL

Influenza and COVID-19 Combination A

Intervention Type BIOLOGICAL

Combined influenza and Pfizer-BioNTech COVID-19 Vaccine

Placebo

Intervention Type BIOLOGICAL

Saline Solution

Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Group Type ACTIVE_COMPARATOR

Licensed influenza vaccine

Intervention Type BIOLOGICAL

Licensed influenza vaccine

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine

Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo

Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo

Group Type EXPERIMENTAL

Influenza and COVID-19 Combination B

Intervention Type BIOLOGICAL

Combined influenza and Pfizer-BioNTech COVID-19 vaccine

Placebo

Intervention Type BIOLOGICAL

Saline Solution

Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group

Group Type ACTIVE_COMPARATOR

Licensed influenza vaccine

Intervention Type BIOLOGICAL

Licensed influenza vaccine

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine

Cohort 3 Arm E:Influenza and COVID-19 Combination B

Cohort 3 Arm E:Influenza and COVID-19 Combination B

Group Type EXPERIMENTAL

Influenza and COVID-19 Combination B

Intervention Type BIOLOGICAL

Combined influenza and Pfizer-BioNTech COVID-19 vaccine

Cohort 3 Arm F: COVID-19 vaccine

Cohort 3 Arm F: COVID-19 vaccine

Group Type ACTIVE_COMPARATOR

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine

Cohort 3 Arm G: Licensed influenza vaccine

Cohort 3 Arm G: Licensed influenza vaccine

Group Type ACTIVE_COMPARATOR

Licensed influenza vaccine

Intervention Type BIOLOGICAL

Licensed influenza vaccine

Cohort 3 Arm H: Investigational influenza vaccine

Cohort 3 Arm H: Investigational influenza vaccine

Group Type ACTIVE_COMPARATOR

Investigational influenza vaccine

Intervention Type BIOLOGICAL

Investigational influenza vaccine

Interventions

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Influenza and COVID-19 Combination A

Combined influenza and Pfizer-BioNTech COVID-19 Vaccine

Intervention Type BIOLOGICAL

Licensed influenza vaccine

Licensed influenza vaccine

Intervention Type BIOLOGICAL

COVID-19 Vaccine

Pfizer-BioNTech COVID-19 vaccine

Intervention Type BIOLOGICAL

Influenza and COVID-19 Combination B

Combined influenza and Pfizer-BioNTech COVID-19 vaccine

Intervention Type BIOLOGICAL

Placebo

Saline Solution

Intervention Type BIOLOGICAL

Investigational influenza vaccine

Investigational influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria

* Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
* Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration.

Please refer to the study contact for further eligibility details
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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North Alabama Research Center

Athens, Alabama, United States

Site Status

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Site Status

AMR Clinical

Mobile, Alabama, United States

Site Status

HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Foothills Research Center/ CCT Research

Phoenix, Arizona, United States

Site Status

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Site Status

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

Site Status

Baptist Health Center For Clinical Research

Little Rock, Arkansas, United States

Site Status

Hope Clinical Research, Inc.

Canoga Park, California, United States

Site Status

Ascada Health PC dba Ascada Research

Fullerton, California, United States

Site Status

Orange County Research Center

Lake Forest, California, United States

Site Status

Ark Clinical Research

Long Beach, California, United States

Site Status

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Acclaim Clinical Research

San Diego, California, United States

Site Status

Bayview Research Group, LLC

Valley Village, California, United States

Site Status

Synexus Clinical Research US, Inc.

Vista, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Tampa Bay Medical Research

Clearwater, Florida, United States

Site Status

Universal Axon Clinical Research, LLC

Doral, Florida, United States

Site Status

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States

Site Status

Finlay Medical Research

Greenacres City, Florida, United States

Site Status

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status

Best Quality Research,Inc.

Hialeah, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States

Site Status

Miami Clinical Research

Miami, Florida, United States

Site Status

Gerardo Polanco, MD

Miami, Florida, United States

Site Status

Research Institute of South Florida

Miami, Florida, United States

Site Status

Entrust Clinical Research

Miami, Florida, United States

Site Status

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Site Status

Clinical Site Partners LLC, dba Flourish Research

Miami, Florida, United States

Site Status

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Site Status

Angels Clinical Research Institute

Miami Lakes, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Innovation Medical Research Center

Palmetto Bay, Florida, United States

Site Status

DBC Research USA

Pembroke Pines, Florida, United States

Site Status

Angels Clinical Research Institute

Tampa, Florida, United States

Site Status

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, United States

Site Status

AGILE Clinical Research Trials, LLC

Sandy Springs, Georgia, 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 Prime

Idaho Falls, Idaho, United States

Site Status

Velocity Clinical Research, Boise

Meridian, Idaho, United States

Site Status

Solaris Clinical Research

Meridian, Idaho, United States

Site Status

Synexus Clinical Research US, Inc.

Chicago, Illinois, United States

Site Status

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status

Koch Family Medicine

Morton, Illinois, United States

Site Status

Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States

Site Status

AMR Clinical

Wichita, Kansas, United States

Site Status

Pharmaron

Baltimore, Maryland, United States

Site Status

Jadestone Clinical Research

Silver Spring, Maryland, United States

Site Status

Headlands Research - Detroit

Southfield, Michigan, United States

Site Status

Revival Research Institute, LLC

Sterling Heights, Michigan, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, United States

Site Status

Saint Louis University Center for Vaccine Development

St Louis, Missouri, United States

Site Status

Sundance Clinical Research

St Louis, Missouri, United States

Site Status

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Site Status

Quality Clinical Research

Omaha, Nebraska, United States

Site Status

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Site Status

McGill Family Practice

Papillion, Nebraska, United States

Site Status

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Site Status

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Site Status

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status

Duke Vaccine and Trials Unit

Durham, North Carolina, United States

Site Status

Accellacare - Hickory

Hickory, North Carolina, United States

Site Status

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Site Status

Accellacare - Rocky Mount

Rocky Mount, North Carolina, United States

Site Status

Accellacare - Wilmington

Wilmington, North Carolina, United States

Site Status

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States

Site Status

Trial Management Associates, LLC

Wilmington, North Carolina, United States

Site Status

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Velocity Clinical Research, Cincinnati, Mt. Auburn

Cincinnati, Ohio, United States

Site Status

Synexus Clinical Research US, Inc.

Cincinnati, Ohio, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Velocity Clinical Research, Medford

Medford, Oregon, United States

Site Status

Trial Management Associates, LLC

Myrtle Beach, South Carolina, United States

Site Status

Trial Management Associates

Myrtle Beach, South Carolina, United States

Site Status

Internal Medicine and Pediatric Associates of Bristol

Bristol, Tennessee, United States

Site Status

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Site Status

New Phase Research and Development

Knoxville, Tennessee, United States

Site Status

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Site Status

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States

Site Status

Benchmark Research

Austin, Texas, United States

Site Status

Tekton Research, LLC.

Austin, Texas, United States

Site Status

Orion Clinical Research

Austin, Texas, United States

Site Status

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, United States

Site Status

DFW Clinical Research

Dallas, Texas, United States

Site Status

Benchmark Research

Fort Worth, Texas, United States

Site Status

Texas Health Family Care

Fort Worth, Texas, United States

Site Status

Santa Clara Family Clinic

Houston, Texas, United States

Site Status

SMS Clinical Research

Mesquite, Texas, United States

Site Status

ACRC Trials (Administrative Location)

Plano, Texas, United States

Site Status

ACRC TRIALS / North Texas Family Medicine

Plano, Texas, United States

Site Status

AIM Trials, LLC

Plano, Texas, United States

Site Status

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, United States

Site Status

IMA Clinical Research San Antonio

San Antonio, Texas, United States

Site Status

DM Clinical Research, Martin Diagnostic Clinic

Tomball, Texas, United States

Site Status

Northwest Houston Heart Center

Tomball, Texas, United States

Site Status

AMR Clinical

Layton, Utah, United States

Site Status

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

Salt Lake City, Utah, United States

Site Status

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Site Status

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Site Status

AMR Clinical

Norfolk, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5261002

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

Other Identifiers

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NCT06178991

Identifier Type: REGISTRY

Identifier Source: secondary_id

C5261002

Identifier Type: -

Identifier Source: org_study_id

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