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

This study is to learn about flu and COVID vaccines, either alone or when mixed together.Healthy people aged 18 or older can join. Participants will get one shot in each arm,either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, andparticipants need to visit the research site at least 3 times.

Detailed Description

Not Provided

Completed
Influenza,Human
COVID-19

Biological: Investigational Influenza Vaccine

Investigational Influenza Vaccine

Biological: COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

Combination Product: Influenza and COVID Combination Vaccine

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Biological: Licensed Influenza Vaccine 1

Licensed Influenza Vaccine 1

Biological: Licensed Influenza Vaccine 2

Licensed Influenza Vaccine 2

Other: Placebo

Saline

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 judgment of the investigator to be eligible for
inclusion in the study.

Exclusion Criteria:

- Vaccination with any investigational or licensed 2024-2025 season formulation
influenza or COVID-19 vaccine.

- Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior
to Day 1

Please refer to the study contact for further eligibility details.

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

Orange County Research Center
Lake Forest 5364514, 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

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

Headlands Research Orlando
Orlando 4167147, 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

Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield 4409896, Missouri 4398678, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield 4409896, Missouri 4398678, United States

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

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

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

Pfizer CT.gov Call Center, Study Director
Pfizer

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