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, Alabama, United States

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

AMR Clinical
Mobile, Alabama, United States

HOPE Research Institute
Phoenix, Arizona, United States

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

Scottsdale Clinical Trials
Scottsdale, Arizona, United States

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

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

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

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

Orange County Research Center
Lake Forest, California, United States

Ark Clinical Research
Long Beach, California, United States

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

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

Acclaim Clinical Research
San Diego, California, United States

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

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

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

Tampa Bay Medical Research
Clearwater, Florida, United States

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

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

Finlay Medical Research
Greenacres City, Florida, United States

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

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

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

Miami Clinical Research
Miami, Florida, United States

Gerardo Polanco, MD
Miami, Florida, United States

Research Institute of South Florida
Miami, Florida, United States

Entrust Clinical Research
Miami, Florida, United States

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

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

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

Angels Clinical Research Institute
Miami Lakes, Florida, United States

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

Innovation Medical Research Center
Palmetto Bay, Florida, United States

DBC Research USA
Pembroke Pines, Florida, United States

Angels Clinical Research Institute
Tampa, Florida, United States

Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States

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

Clinical Research Atlanta
Stockbridge, Georgia, United States

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

Clinical Research Prime
Idaho Falls, Idaho, United States

Velocity Clinical Research, Boise
Meridian, Idaho, United States

Solaris Clinical Research
Meridian, Idaho, United States

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

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

Koch Family Medicine
Morton, Illinois, United States

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

AMR Clinical
Wichita, Kansas, United States

Pharmaron
Baltimore, Maryland, United States

Jadestone Clinical Research
Silver Spring, Maryland, United States

Headlands Research - Detroit
Southfield, Michigan, United States

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

Clinical Research Professionals
Chesterfield, Missouri, United States

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

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

Sundance Clinical Research
St Louis, Missouri, United States

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

Quality Clinical Research
Omaha, Nebraska, United States

Velocity Clinical Research, Omaha
Omaha, Nebraska, United States

McGill Family Practice
Papillion, Nebraska, United States

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

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

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

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

Accellacare - Hickory
Hickory, North Carolina, United States

Monroe Biomedical Research
Monroe, North Carolina, United States

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

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

Accellacare - Wilmington
Wilmington, North Carolina, United States

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

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

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

CTI Clinical Research Center
Cincinnati, Ohio, United States

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

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

Lynn Health Science Institute
Oklahoma City, Oklahoma, United States

Velocity Clinical Research, Medford
Medford, Oregon, United States

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

Trial Management Associates
Myrtle Beach, South Carolina, United States

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

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

New Phase Research and Development
Knoxville, Tennessee, United States

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

Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States

Benchmark Research
Austin, Texas, United States

Tekton Research, LLC.
Austin, Texas, United States

Orion Clinical Research
Austin, Texas, United States

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

DFW Clinical Research
Dallas, Texas, United States

Benchmark Research
Fort Worth, Texas, United States

Texas Health Family Care
Fort Worth, Texas, United States

Santa Clara Family Clinic
Houston, Texas, United States

SMS Clinical Research
Mesquite, Texas, United States

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

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

AIM Trials, LLC
Plano, Texas, United States

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

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

DM Clinical Research, Martin Diagnostic Clinic
Tomball, Texas, United States

Northwest Houston Heart Center
Tomball, Texas, United States

AMR Clinical
Layton, Utah, United States

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

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

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

AMR Clinical
Norfolk, Virginia, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

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