One shot, two protections? a new vaccine aims to tackle flu and COVID together

NCT ID NCT06683352

Completed ⭐️ VACCINE ⭐️ Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

The trial has finished. Results may not be published yet.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial is testing whether a single vaccine can protect against both influenza and COVID-19. Healthy adults aged 18 and older will receive either a combined vaccine, separate flu and COVID shots, or a placebo. The study will monitor safety and immune response over about six months to see if the combined approach works as well as separate vaccines.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Combined investigational influenza and COVID-19 vaccine
What this could lead to: If successful, this could lead to a single shot that protects against both flu and COVID-19, simplifying vaccination and improving coverage.
What could go wrong: This is an early-stage trial, so the vaccine may not produce a strong enough immune response or could cause unexpected side effects. Success in this phase does not guarantee approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

1,353 people

The number who actually took part.

Started

Nov 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 INFLUENZA,HUMAN

Contacts and locations

Locations

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, 03801, United States
Artemis Institute for Clinical Research

San Diego, California, 92103, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, 65802, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center

Springfield, Missouri, 65807, United States
Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States
Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States
Clinical Research Consulting

Milford, Connecticut, 06460, United States
Clinical Research Professionals

Chesterfield, Missouri, 63005, United States
DM Clinical Research- Cyfair

Houston, Texas, 77065, United States
Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, 77375, United States
East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States
Headlands Research Orlando

Orlando, Florida, 32819, United States
Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States
J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States
Las Vegas Clinical Trials

Las Vegas, Nevada, 89030, United States
Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States
Orange County Research Center

Lake Forest, California, 92630, United States
Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States
SMS Clinical Research

Mesquite, Texas, 75149, United States
Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

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