Official Title
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Brief Summary

The purpose of this study is to understand the safety and effects of a combined influenzaand COVID-19 vaccine. This combined vaccine is compared to separate vaccines for theprotection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that canspread easily from one person to another and cause body aches, fever, cough, and othersymptoms. Giving both influenza and COVID-19 vaccines together against influenza andSARS-CoV-2 could provide great benefits to both patients and caregivers in terms ofsimple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccinationgroups (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 thefollowing: - 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 thefollowing: - 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 thefollowing: - 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 incohort 3 will receive 1 injection as per their assigned study group at Visit 1. Theparticipants will be followed for about 6 months. During this time, researchers willassess safety and the body's reaction to the vaccination over approximately 6 months.This will help understand if the study medicine is safe.

Detailed Description

Not Provided

Completed
Influenza
COVID-19

Biological: Influenza and COVID-19 Combination A

Combined influenza and Pfizer-BioNTech COVID-19 Vaccine

Biological: Licensed influenza vaccine

Licensed influenza vaccine

Biological: COVID-19 Vaccine

Pfizer-BioNTech COVID-19 vaccine

Biological: Influenza and COVID-19 Combination B

Combined influenza and Pfizer-BioNTech COVID-19 vaccine

Biological: Placebo

Saline Solution

Biological: Investigational influenza vaccine

Investigational influenza vaccine

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 64 Years
Countries
United States
Locations

North Alabama Research Center
Athens 4830668, Alabama 4829764, United States

Accel Research Sites - Birmingham Clinical Research Unit
Birmingham 4049979, Alabama 4829764, United States

Medical Affiliated Research Center
Huntsville 4068590, Alabama 4829764, United States

Alliance for Multispecialty Research, LLC
Mobile 4076598, Alabama 4829764, United States

Hope Research Institute
Phoenix 5308655, Arizona 5551752, United States

The Pain Center of Arizona
Phoenix 5308655, Arizona 5551752, United States

HOPE Research Institute
Phoenix 5308655, Arizona 5551752, United States

Foothills Research Center/ CCT Research
Phoenix 5308655, Arizona 5551752, United States

Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752, United States

Alliance for Multispecialty Research, LLC
Tempe 5317058, Arizona 5551752, United States

Baptist Health Center For Clinical Research
Little Rock 4119403, Arkansas 4099753, United States

Velocity Clinical Research, Banning
Banning 5326032, California 5332921, United States

Hope Clinical Research, Inc.
Canoga Park 5333913, California 5332921, United States

West Coast Research
Dublin 5344157, California 5332921, United States

Ascada Health PC dba Ascada Research
Fullerton 5351247, California 5332921, United States

Marvel Clinical Research
Huntington Beach 5358705, California 5332921, United States

Velocity Clinical Research, San Diego
La Mesa 5363990, California 5332921, United States

Orange County Research Center
Lake Forest 5364514, California 5332921, United States

Ark Clinical Research
Long Beach 5367929, California 5332921, United States

Collaborative Neuroscience Research, LLC
Los Alamitos 5368304, California 5332921, United States

Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921, United States

Kaiser Permanente
Los Angeles 5368361, California 5332921, United States

Velocity Clinical Research, Westlake
Los Angeles 5368361, California 5332921, United States

Velocity Clinical Research, North Hollywood
North Hollywood 5377654, California 5332921, United States

Pasadena Clinical Trials - South Arroyo Parkway
Pasadena 5381396, California 5332921, United States

Artemis Institute for Clinical Research
Riverside 5387877, California 5332921, United States

Benchmark Research
Sacramento 5389489, California 5332921, United States

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921, United States

Optimal Research San Diego
San Diego 5391811, California 5332921, United States

Acclaim Clinical Research
San Diego 5391811, California 5332921, United States

Orange County Research Center
Tustin 5404119, California 5332921, United States

Bayview Research Group, LLC
Valley Village 7284982, California 5332921, United States

Synexus Clinical Research US, Inc.
Vista 5406602, California 5332921, United States

Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921, United States

Clinical Research Consulting
Milford 4838652, Connecticut 4831725, United States

Tampa Bay Medical Research
Clearwater 4151316, Florida 4155751, United States

Universal Axon Clinical Research, LLC
Doral 4153471, Florida 4155751, United States

Proactive Clinical Research,LLC
Fort Lauderdale 4155966, Florida 4155751, United States

Finlay Medical Research
Greenacres City 4157467, Florida 4155751, United States

Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751, United States

Best Quality Research,Inc.
Hialeah 4158476, Florida 4155751, United States

Research Centers of America ( Hollywood )
Hollywood 4158928, Florida 4155751, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville 4160021, Florida 4155751, United States

Optimal Research
Melbourne 4163971, Florida 4155751, United States

Angels Clinical Research Institute
Miami 4164138, Florida 4155751, United States

Miami Clinical Research
Miami 4164138, Florida 4155751, United States

Gerardo Polanco, MD
Miami 4164138, Florida 4155751, United States

Research Institute of South Florida
Miami 4164138, Florida 4155751, United States

Entrust Clinical Research
Miami 4164138, Florida 4155751, United States

Miami Dade Medical Research Institute, LLC
Miami 4164138, Florida 4155751, United States

Clinical Site Partners LLC, dba Flourish Research
Miami 4164138, Florida 4155751, United States

Palm Springs Community Health Center
Miami Lakes 4164186, Florida 4155751, United States

Panax Clinical Research
Miami Lakes 4164186, Florida 4155751, United States

Angels Clinical Research Institute
Miami Lakes 4164186, Florida 4155751, United States

Clinical Neuroscience Solutions, Inc.
Orlando 4167147, Florida 4155751, United States

Innovation Medical Research Center
Palmetto Bay 4167634, Florida 4155751, United States

DBC Research USA
Pembroke Pines 4168139, Florida 4155751, United States

United Medical Research
Port Orange 4169156, Florida 4155751, United States

Angels Clinical Research Institute
Tampa 4174757, Florida 4155751, United States

Synexus Clinical Research US, Inc.
Atlanta 4180439, Georgia 4197000, United States

Centricity Research Columbus Georgia Multispecialty
Columbus 4188985, Georgia 4197000, United States

Tekton Research, LLC.
Lawrenceville 4205196, Georgia 4197000, United States

AGILE Clinical Research Trials, LLC
Sandy Springs 4221333, Georgia 4197000, United States

Velocity Clinical Research, Savannah
Savannah 4221552, Georgia 4197000, United States

Clinical Research Atlanta
Stockbridge 4224681, Georgia 4197000, United States

East-West Medical Research Institute
Honolulu 5856195, Hawaii 5855797, United States

Clinical Research Prime
Idaho Falls 5596475, Idaho 5596512, United States

Velocity Clinical Research, Boise
Meridian 5600685, Idaho 5596512, United States

Solaris Clinical Research
Meridian 5600685, Idaho 5596512, United States

Synexus Clinical Research US, Inc.
Chicago 4887398, Illinois 4896861, United States

Great Lakes Clinical Trials - Ravenswood
Chicago 4887398, Illinois 4896861, United States

Great Lakes Clinical Trials - Gurnee
Gurnee 4894861, Illinois 4896861, United States

Koch Family Medicine
Morton 4902754, Illinois 4896861, United States

Affinity Health
Oak Brook 4904277, Illinois 4896861, United States

Velocity Clinical Research, Sioux City
Sioux City 4876523, Iowa 4862182, United States

Alliance for Multispecialty Research, LLC
Wichita 4281730, Kansas 4273857, United States

Pharmaron
Baltimore 4347778, Maryland 4361885, United States

Advanced Primary and Geriatric Care - CCT Research
Rockville 4367175, Maryland 4361885, United States

Jadestone Clinical Research
Silver Spring 4369596, Maryland 4361885, United States

Michigan Center of Medical Research (MICHMER)
Farmington Hills 4992523, Michigan 5001836, United States

Headlands Research - Detroit
Southfield 5010636, Michigan 5001836, United States

Revival Research Institute, LLC
Sterling Heights 5011148, Michigan 5001836, United States

Oakland Medical Research
Troy 5012639, Michigan 5001836, United States

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678, United States

Alliance for Multispecialty Research, LLC
Kansas City 4393217, Missouri 4398678, United States

DelRicht Research - Springfield
Springfield 4409896, Missouri 4398678, United States

DelRicht Research
Springfield 4409896, Missouri 4398678, United States

Saint Louis University Center for Vaccine Development
St Louis 4407066, Missouri 4398678, United States

Sundance Clinical Research
St Louis 4407066, Missouri 4398678, United States

Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708, United States

Quality Clinical Research
Omaha 5074472, Nebraska 5073708, United States

Velocity Clinical Research, Omaha
Omaha 5074472, Nebraska 5073708, United States

McGill Family Practice
Papillion 5074792, Nebraska 5073708, United States

Las Vegas Clinical Trials
Las Vegas 5506956, Nevada 5509151, United States

Wr-Crcn, Llc
Las Vegas 5506956, Nevada 5509151, United States

Excel Clinical Research, LLC
Las Vegas 5506956, Nevada 5509151, United States

Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151, United States

ActivMed Practices & Research, LLC.
Portsmouth 5091383, New Hampshire 5090174, United States

IMA Clinical Research Warren
Warren Township 8299577, New Jersey 5101760, United States

Albuquerque Clinical Trials, Inc.
Albuquerque 5454711, New Mexico 5481136, United States

NYU Langone Health
New York 5128581, New York 5128638, United States

Rochester Clinical Research, LLC
Rochester 5134086, New York 5128638, United States

Duke Vaccine and Trials Unit
Durham 4464368, North Carolina 4482348, United States

Accellacare - Hickory
Hickory 4470778, North Carolina 4482348, United States

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348, United States

M3 Wake Research, Inc.
Raleigh 4487042, North Carolina 4482348, United States

Accellacare - Rocky Mount
Rocky Mount 4488762, North Carolina 4482348, United States

Accellacare - Salisbury
Salisbury 4489985, North Carolina 4482348, United States

Accellacare - Wilmington
Wilmington 4499379, North Carolina 4482348, United States

Trial Management Associates - Wilmington - Floral Parkway
Wilmington 4499379, North Carolina 4482348, United States

Trial Management Associates, LLC
Wilmington 4499379, North Carolina 4482348, United States

Accellacare - Winston-Salem
Winston-Salem 4499612, North Carolina 4482348, United States

CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418, United States

Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati 4508722, Ohio 5165418, United States

Velocity Clinical Research, Mt. Auburn
Cincinnati 4508722, Ohio 5165418, United States

Synexus Clinical Research US, Inc.
Cincinnati 4508722, Ohio 5165418, United States

Centricity Research Columbus Ohio Multispecialty
Columbus 4509177, Ohio 5165418, United States

Lynn Institute of Norman
Norman 4543762, Oklahoma 4544379, United States

Lynn Health Science Institute
Oklahoma City 4544349, Oklahoma 4544379, United States

Velocity Clinical Research, Medford
Medford 5740099, Oregon 5744337, United States

Capital Area Research, LLC
Camp Hill 5182928, Pennsylvania 6254927, United States

DM Clinical Research - Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, United States

Main Street Physician's Care
Little River 4585421, South Carolina 4597040, United States

Trial Management Associates, LLC
Myrtle Beach 4588718, South Carolina 4597040, United States

Trial Management Associates
Myrtle Beach 4588718, South Carolina 4597040, United States

Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040, United States

Internal Medicine and Pediatric Associates of Bristol
Bristol 4608657, Tennessee 4662168, United States

Alliance for Multispecialty Research, LLC
Knoxville 4634946, Tennessee 4662168, United States

New Phase Research and Development
Knoxville 4634946, Tennessee 4662168, United States

Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville 4634946, Tennessee 4662168, United States

Alliance for Multispecialty Research, LLC
Knoxville 4634946, Tennessee 4662168, United States

Clinical Neuroscience Solutions Inc.
Memphis 4641239, Tennessee 4662168, United States

Benchmark Research
Austin 4671654, Texas 4736286, United States

Optimal Research
Austin 4671654, Texas 4736286, United States

Tekton Research, LLC.
Austin 4671654, Texas 4736286, United States

Orion Clinical Research
Austin 4671654, Texas 4736286, United States

Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville 4676740, Texas 4736286, United States

ACRC TRIALS / Family Medicine Associates of Texas
Carrollton 4679195, Texas 4736286, United States

DFW Clinical Research
Dallas 4684888, Texas 4736286, United States

Synexus Clinical Research US, Inc.
Dallas 4684888, Texas 4736286, United States

DFW Clinical Research
Dallas 4684888, Texas 4736286, United States

North Texas Infectious Diseases Consultants, P.A
Dallas 4684888, Texas 4736286, United States

Benchmark Research
Fort Worth 4691930, Texas 4736286, United States

Texas Health Family Care
Fort Worth 4691930, Texas 4736286, United States

University of Texas Medical Branch
Galveston 4692883, Texas 4736286, United States

DM Clinical Research - Bellaire
Houston 4699066, Texas 4736286, United States

Santa Clara Family Clinic
Houston 4699066, Texas 4736286, United States

SMS Clinical Research
Mesquite 4710826, Texas 4736286, United States

ACRC Trials (Administrative Location)
Plano 4719457, Texas 4736286, United States

ACRC TRIALS / North Texas Family Medicine
Plano 4719457, Texas 4736286, United States

AIM Trials, LLC
Plano 4719457, Texas 4736286, United States

Clinical Trials of Texas, LLC dba Flourish Research
San Antonio 4726206, Texas 4736286, United States

Clinical Trials of Texas, LLC
San Antonio 4726206, Texas 4736286, United States

IMA Clinical Research San Antonio
San Antonio 4726206, Texas 4736286, United States

Sugar Lakes Family Practice, PA
Sugar Land 4734825, Texas 4736286, United States

DM Clinical Research - MDC
Tomball 4737094, Texas 4736286, United States

Northwest Houston Heart Center
Tomball 4737094, Texas 4736286, United States

Alliance for Multispecialty Research, LLC
Layton 5777107, Utah 5549030, United States

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030, United States

J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City 5780993, Utah 5549030, United States

J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan 5781770, Utah 5549030, United States

Velocity Clinical Research, Salt Lake City
West Jordan 5784549, Utah 5549030, United States

Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928, United States

Health Research of Hampton Roads, Inc.
Newport News 4776024, Virginia 6254928, United States

Alliance for Multispecialty Research, LLC
Norfolk 4776222, Virginia 6254928, United States

Clinical Research Partners, LLC
Richmond 4781708, Virginia 6254928, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
MeSH Terms
Influenza, Human
COVID-19
Influenza Vaccines
COVID-19 Vaccines