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Learning how flu and COVID-19 vaccines work in healthy adults

A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS

Phase1; Phase2 Interventional BioNTech SE · NCT06821061

This study is testing how well the flu and COVID-19 vaccines work alone or together in healthy adults to see how they affect the immune system.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment2050 (estimated)
Ages18 Years and up
SexAll
SponsorBioNTech SE Industry-sponsored
Locations26 sites (Anaheim, California and 25 other locations)
Trial IDNCT06821061 on ClinicalTrials.gov

What this trial studies

This study aims to understand the immune response generated by the flu and COVID-19 vaccines when administered separately or in combination. Healthy participants aged 18 and older will receive one shot of either a flu vaccine, a COVID-19 vaccine, or a combination of both. The study will last approximately six months, during which participants will visit the clinical site at least four times for monitoring and assessments. The goal is to gather data on how these vaccines interact and their effectiveness in healthy individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 years and older who have not received any flu or COVID-19 vaccines in the specified time frame.

Not a fit: Patients who have recently received any flu or COVID-19 vaccines or antiviral therapies for influenza may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance vaccine strategies and improve public health responses to influenza and COVID-19.

How similar studies have performed: While studies on individual vaccines are common, this approach of combining flu and COVID-19 vaccines is relatively novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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 judgement of the investigator to be eligible for inclusion in the study

Exclusion criteria:

* Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
* Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
* Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1.

Refer to the study contact for further eligibility details

Where this trial is running

Anaheim, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions InfluenzaCOVID-19
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.