CD2H COVID-19

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

Purpose

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 9000 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance. Cohort 1: Around 4500 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 the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm. - Group B: COVID-19 vaccine, given at the same time to the right arm and licensed influenza vaccine in the left arm. Cohort 2: Around 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 the right arm and placebo in the left arm. - Group D: COVID-19 vaccine, given at the same time in the right arm and licenced influenza vaccine in the left arm. All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.

Conditions

Influenza
COVID-19

Eligibility

Eligible Ages: Between 18 Years and 64 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Double (Participant, Investigator)
Masking Description: 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.

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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	Biological: Influenza and COVID-19 Combination A Combined influenza and Pfizer-BioNTech COVID-19 Vaccine Biological: Placebo Saline Solution
Active Comparator 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	Biological: Licensed influenza vaccine Licensed influenza vaccine Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 vaccine
Experimental 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	Biological: Influenza and COVID-19 Combination B Combined influenza and Pfizer-BioNTech COVID-19 vaccine Biological: Placebo Saline Solution
Active Comparator 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	Biological: Licensed influenza vaccine Licensed influenza vaccine Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 vaccine

Recruiting Locations

North Alabama Research Center
Athens, Alabama 35611

Accel Research Sites Network - Birmingham Clinical Research Unit
Birmingham, Alabama 35216

Alliance for Multispecialty Research, LLC
Mobile, Alabama 36608

HOPE Research Institute
Phoenix, Arizona 85018

The Pain Center of Arizona
Phoenix, Arizona 85018

Foothills Research Center/ CCT Research
Phoenix, Arizona 85044

Scottsdale Clinical Trials
Scottsdale, Arizona 85260

Alliance for Multispecialty Research, LLC
Tempe, Arizona 85281

Baptist Health Center for Clinical Research
Little Rock, Arkansas 72205

Hope Clinical Research, Inc.
Canoga Park, California 91303

Ascada Health PC dba Ascada Research
Fullerton, California 92835

Orange County Research Center
Lake Forest, California 92630

Ark Clinical Research
Long Beach, California 90815

Collaborative Neuroscience Research, LLC
Los Alamitos, California 90720

Artemis Institute for Clinical Research
San Diego, California 92103

Optimal Research San Diego
San Diego, California 92108

Acclaim Clinical Research
San Diego, California 92120

Orange County Research Center
Tustin, California 92780

Bayview Research Group, LLC
Valley Village, California 91607

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Tampa Bay Medical Research
Clearwater, Florida 33761

Universal Axon Clinical Research, LLC
Doral, Florida 33166

Proactive Clinical Research,LLC
Fort Lauderdale, Florida 33308

Finlay Medical Research
Greenacres City, Florida 33467

Indago Research & Health Center, Inc
Hialeah, Florida 33012

Best Quality Research,Inc.
Hialeah, Florida 33016

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida 32256

Palm Springs Community Health Center
Miami Lakes, Florida 33014

Angels Clinical Research Institute
Miami, Florida 33122

Miami Clinical Research
Miami, Florida 33155

Gerardo Polanco, MD
Miami, Florida 33156

Research Institute of South Florida
Miami, Florida 33173

Entrust Clinical Research
Miami, Florida 33176

Miami Dade Medical Research Institute, LLC
Miami, Florida 33176

Clinical Site Partners LLC, dba Flourish Research
Miami, Florida 33186

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801

Innovation Medical Research Center
Palmetto Bay, Florida 33157

DBC Research USA
Pembroke Pines, Florida 33029

Angels Clinical Research Institute
Tampa, Florida 33614

Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia 31904

AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia 30328

Clinical Research Atlanta
Stockbridge, Georgia 30281

East-West Medical Research Institute
Honolulu, Hawaii 96814

Clinical Research Prime
Idaho Falls, Idaho 83404

Velocity Clinical Research, Boise
Meridian, Idaho 83642

Solaris Clinical Research
Meridian, Idaho 83646

Synexus Clinical Research US, Inc.
Chicago, Illinois 60602

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640

Koch Family Medicine
Morton, Illinois 61550

Velocity Clinical Research, Sioux City
Sioux City, Iowa 51106

Alliance for Multispecialty Research, LLC
Wichita, Kansas 67207

Pharmaron
Baltimore, Maryland 21201

Jadestone Clinical Research
Silver Spring, Maryland 20904

Headlands Research - Detroit
Southfield, Michigan 48034

Revival Research Institute
Sterling Heights, Michigan 48312

Clinical Research Professionals
Chesterfield, Missouri 63005

Alliance for Multispecialty Research, LLC
Kansas City, Missouri 64114

Saint Louis University Center for Vaccine Development
Saint Louis, Missouri 63104

Sundance Clinical Research
Saint Louis, Missouri 63141

Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803

Quality Clinical Research
Omaha, Nebraska 68114

Velocity Clinical Research, Omaha
Omaha, Nebraska 68134

McGill Family Practice
Papillion, Nebraska 68046

Las Vegas Clinical Trials
North Las Vegas, Nevada 89030

IMA Clinical Research Warren
Warren, New Jersey 07059

Rochester Clinical Research, LLC
Rochester, New York 14609

Duke Vaccine and Trials Unit
Durham, North Carolina 27703

Accellacare - Hickory
Hickory, North Carolina 28601

Monroe Biomedical Research
Monroe, North Carolina 28112

M3 Wake Research, Inc.
Raleigh, North Carolina 27612

Accellacare - Rocky Mount
Rocky Mount, North Carolina 27804

Accellacare - Wilmington
Wilmington, North Carolina 28401

Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina 28403

Trial Management Associates, LLC
Wilmington, North Carolina 28403

Accellacare - Winston-Salem
Winston-Salem, North Carolina 27103

CTI Clinical Research Center
Cincinnati, Ohio 45212

Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio 45219

Synexus Clinical Research US, Inc.
Cincinnati, Ohio 45236

Lynn Health Science Institute
Oklahoma City, Oklahoma 73112

Velocity Clinical Research, Medford
Medford, Oregon 97504

Main Street Physician's Care
Little River, South Carolina 29566

Trial Management Associates
Myrtle Beach, South Carolina 29572

Internal Medicine and Pediatric Associates of Bristol
Bristol, Tennessee 37620

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee 37909

New Phase Research and Development
Knoxville, Tennessee 37909

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee 37920

Clinical Neuroscience Solutions Inc.
Memphis, Tennessee 38119

Benchmark Research
Austin, Texas 78705

Tekton Research, LLC.
Austin, Texas 78745

Orion Clinical Research
Austin, Texas 78759

Headlands Horizons LLC
Brownsville, Texas 78526

DFW Clinical Research
Dallas, Texas 75234

Benchmark Research
Fort Worth, Texas 76135

Texas Health Family Care
Fort Worth, Texas 76135

Santa Clara Family Clinic
Houston, Texas 77087

SMS Clinical Research
Mesquite, Texas 75149

ACRC Trials (Administrative Location)
Plano, Texas 75024

ACRC TRIALS / North Texas Family Medicine
Plano, Texas 75093

AIM Trials, LLC
Plano, Texas 75093

Clinical Trials of Texas, LLC
San Antonio, Texas 78229

IMA Clinical Research San Antonio
San Antonio, Texas 78229

DM Clinical Research
Tomball, Texas 77375

Northwest Houston Heart Center
Tomball, Texas 77375

Alliance for Multispecialty Research, LLC
Layton, Utah 84041

J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah 84121

Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088

Health Research of Hampton Roads, Inc.
Newport News, Virginia 23606

Alliance for Multispecialty Research, LLC
Norfolk, Virginia 23502

More Details

NCT ID: NCT06178991
Status: Recruiting
Sponsor: BioNTech SE

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.