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

Active, not recruiting
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, California, United States

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

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

Clinical Research Consulting
Milford, Connecticut, United States

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

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

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

Headlands Research Orlando
Orlando, Florida, United States

Clinical Research Atlanta
Stockbridge, Georgia, United States

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

Clinical Research Professionals
Chesterfield, Missouri, United States

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

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

Velocity Clinical Research, Omaha
Omaha, Nebraska, United States

Las Vegas Clinical Trials
Las Vegas, Nevada, United States

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

DM Clinical Research- Cyfair
Houston, Texas, United States

SMS Clinical Research
Mesquite, Texas, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, United States

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

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

Charlottesville Medical Research
Charlottesville, Virginia, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
MeSH Terms
COVID-19
Influenza, Human
Vaccines