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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Influenza,Human, COVID-19

In brief

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.

Key facts

Study ID

NCT06683352

Run by

BioNTech SE

People needed

1353

Starts

2024-11-11

Expected to finish

2025-07-15

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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