Official Title
A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
Brief Summary

The purpose of this study is to learn about how the flu and COVID vaccines act when givenalone or when mixed together.This study is seeking healthy participants aged 18 or older. All participants in thisstudy will receive only 1 shot to their arm, either a flu or COVID vaccine, alone ormixed. Participants will take part in this study for about 6 months, and participantswill need to visit the clinical study site at least 4 times.

Detailed Description

Not Provided

Recruiting
Influenza
COVID-19 (Coronavirus Disease 2019)

Biological: Investigational Influenza Vaccine

Investigational Influenza Vaccine

Biological: Investigational COVID-19 Vaccine

Investigational COVID-19 Vaccine

Combination Product: Investigational Influenza and COVID-19 Combination Vaccine

Investigational Combined Influenza and COVID-19 Vaccine

Biological: Licensed Influenza Vaccine 1

Licensed Influenza Vaccine 1

Biological: Licensed Influenza Vaccine 2

Licensed Influenza Vaccine 2

Biological: Licensed Influenza Vaccine 3

Licensed Influenza Vaccine 3

Biological: Licensed COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

Eligibility Criteria

Inclusion criteria:

- Participants 18 years of age or older

- Healthy participants who are determined by medical history, physical examination (if
clinically required), and clinical judgement of the investigator to be eligible for
inclusion in the study

Exclusion criteria:

- Vaccination with any investigational or licensed influenza vaccine within 150 days
of enrollment

- Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of
enrollment.

- Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to
Day 1.

Refer to the study contact for further eligibility details

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Anaheim Clinical Trials, LLC
Anaheim 5323810, California 5332921, United States

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

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

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

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

Clinical Research Consulting
Milford 4838652, Connecticut 4831725, United States

Alliance for Multispecialty Research, LLC
Coral Gables 4151871, Florida 4155751, United States

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

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

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

Clinical Research Atlanta
Stockbridge 4224681, Georgia 4197000, United States

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

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678, United States

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

Upstate Global Health Institute
East Syracuse 5116079, New York 5128638, United States

University of Rochester Medical Center
Rochester 5134086, New York 5128638, United States

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

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

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

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

AMR Clinical
Knoxville 4634946, Tennessee 4662168, United States

AMR Clinical
Knoxville 4634946, Tennessee 4662168, United States

Clinical Research Associates Inc
Nashville 4644585, Tennessee 4662168, United States

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

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

SMS Clinical Research
Mesquite 4710826, Texas 4736286, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball 4737094, Texas 4736286, 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

Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928, United States

Kaiser Permanente Washington Health Research Institute (KPWHRI)
Seattle 5809844, Washington 5815135, United States

Contacts

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

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
MeSH Terms
Influenza, Human
COVID-19