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Flu shot showdown: Cell-Grown vs recombinant vaccine put to the test

NCT ID NCT06518577

Vaccine Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study compares two approved flu vaccines—Flucelvax (made in animal cells) and Flublok (made using a recombinant protein)—in adults aged 18 to 64. Researchers will measure immune responses from blood samples taken before vaccination, one month later, and six months later. The goal is to see which vaccine triggers stronger and longer-lasting protection against circulating influenza viruses.

What this could mean

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

Active substance
two approved influenza vaccines: Flucelvax (cell culture-based) and Flublok (recombinant protein-based)
What this could lead to
If one vaccine proves more effective, it could guide future flu shot recommendations and improve protection against circulating strains.
What could go wrong
This is a phase 4 immunogenicity study, not designed to measure actual illness reduction. Results may not translate to real-world effectiveness.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

606 people

The number who actually took part.

Started

Sep 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 64 years

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: 1. Adults aged 18-64 years that have not received the current season's influenza vaccine 2. English literate 3. Email or text message capability for weekly follow-up 4. Intention of receiving influenza vaccine based on ACIP-CDC guidelines 5. Willing to provide written/electronic informed consent 6. Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits Exclusion Criteria: 1. Receipt of the current season's influenza vaccine (receipt after July 1, 2024) 2. History of severe allergic reaction after a previous dose of any influenza vaccine or to an influenza vaccine component 3. Receipt of any licensed or investigational live vaccine within 6 weeks or non-live vaccine within 2 weeks prior to enrollment in this study or planning receipt of any vaccines between visits 1 and 2 of the study (approximately within 4 weeks after the receipt of study-administered vaccine) 4. History of Guillain-Barré syndrome 5. Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report 6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 7. Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives Temporary Delay Criteria (Visit 1) 1\. History of febrile illness (\> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

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

Influenza

Contacts and locations

Locations

  • ASU Biodesign Institute

    Tempe, Arizona, 85281, United States

  • Centers for Disease Control and Prevention

    Atlanta, Georgia, 30333, United States

  • Department of Family Medicine, University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15260, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • VA Northeast Ohio Healthcare System (VANEOHS)

    Cleveland, Ohio, 44106, United States

  • Valleywise Health Comprehensive Health Center

    Phoenix, Arizona, 85008, United States

  • Washington University IDCRU

    St Louis, Missouri, 63110, United States

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