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Can a lab-made flu vaccine outperform the traditional egg-based shot?

NCT ID NCT05514002

Prevention Sponsor: Centers for Disease Control and Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether a recombinant flu vaccine (made in insect cells) works better than the standard egg-based flu shot at preventing flu illness in adults aged 18 to 64. About 4,000 college students and frontline workers will receive either vaccine and be monitored during flu season. The study aims to see which vaccine reduces flu infections more and helps people recover faster if they do get sick.

What this could mean

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

Active substance
recombinant influenza vaccine (Flublok Quadrivalent) compared to standard-dose egg-based inactivated influenza vaccine (Fluzone Quadrivalent)
What this could lead to
If the recombinant vaccine proves superior, it could offer better protection against flu for working-age adults.
What could go wrong
This is a single-season trial, and results may not apply to all flu strains or older adults. Both vaccines are already licensed, so the difference may be small.

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

3,988 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2023

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

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: * Aged 18-64 years * Comfortable reading and responding to text messages or emails sent in either English, Spanish, or Chinese * Currently enrolled as a student in a college or graduate degree program AND attending in-person classes with other students. OR Currently employed as a frontline worker defined as an occupation that cannot be done from home or alone AND have direct face-to-face contact, defined as being within 6 feet, or about two arms' lengths, with co-workers, patients or the public as part of full-time (at least 20 hours per week) job responsibilities. * Have daily access to the internet and a mobile phone that can send and receive text messages. * Plan to continue to live/work in the study area through May 2023 (if trial season 1) or May 2024 (if trial season 2). For students in college or graduate degree programs, this is defined as living/working in the area excluding brief absences during school vacation periods. Exclusion Criteria: * Lives with another person who is already enrolled in this study as reported by the subject. * Previous hypersensitivity reaction to the study vaccines as reported by the subject. * Has already received current year influenza vaccine on our after July 1, 2022 as reported by the subject.

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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, human

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Florida A&M University

    Tallahassee, Florida, 32307, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Utah

    Salt Lake City, Utah, 84119, United States

More trials for these conditions

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