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COMPLETED
NCT06683352
PHASE1/PHASE2

A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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, and participants need to visit the research site at least 3 times.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1353

Start Date

2024-11-11

Completion Date

2025-07-15

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Investigational Influenza Vaccine

Investigational Influenza Vaccine

BIOLOGICAL

COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

COMBINATION_PRODUCT

Investigational Influenza/COVID-19 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

Locations (22)

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

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Palm Springs Community Health Center

Miami Lakes, 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