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Egg-Free flu vaccine tested in kids: could it be just as good?

NCT ID NCT05513391

Prevention Sponsor: Sanofi Pasteur, a Sanofi Company 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compared a newer recombinant flu vaccine (RIV4, also called Supemtek or Flublok Quadrivalent) to the standard egg-based flu vaccine in 366 children aged 3 to 8 years. The goal was to see if the recombinant vaccine produced a similar immune response and was as safe. The trial was terminated early, so the full results are not available.

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 (RIV4, Supemtek/Flublok Quadrivalent)
What this could lead to
If successful, this could offer a flu vaccine option for young children that is not made with eggs, potentially improving immune response and supply flexibility.
What could go wrong
The trial was terminated early, so results are limited. It was a non-inferiority study, meaning it aimed to show the new vaccine is as good as the existing one, not necessarily better. Early termination may reduce confidence in findings.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

366 people

The number who actually took part.

Started

Nov 2022

Finished

Oct 2023

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

3 to 8 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 3 to 8 years on the day of inclusion * Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * Thrombocytopenia * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment * Personal or family history of Guillain-Barre Syndrome (GBS) * Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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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 immunization

Contacts and locations

Locations

  • AMR - Newton Site Number : 8400021

    Newton, Kansas, 67114, United States

  • Alliance for Multispecialty Research Syracuse Site Number : 8400027

    Syracuse, Utah, 84075-9645, United States

  • Birmingham Pediatric Associates Site Number : 8400023

    Birmingham, Alabama, 35205, United States

  • California Research Foundation Site Number : 8400003

    San Diego, California, 92123-1881, United States

  • Coastal Carolina Research Center Site Number : 8400022

    North Charleston, South Carolina, 29405, United States

  • Coastal Pediatric Research Charleston Site Number : 8400005

    Charleston, South Carolina, 29414, United States

  • Investigational Site Number : 6160001

    Warsaw, 02-647, Poland

  • Investigational Site Number : 6160003

    Bydgoszcz, 85-796, Poland

  • Investigational Site Number : 6160005

    Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

  • Investigational Site Number : 6160006

    Tarnów, 33-100, Poland

  • Investigational Site Number : 6160007

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

  • Investigational Site Number : 6160010

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

  • Investigational Site Number : 6160012

    Wroclaw, 53-149, Poland

  • Investigational Site Number : 7240001

    Móstoles, 28938, Spain

  • Investigational Site Number : 7240004

    Madrid, 28041, Spain

  • Investigational Site Number : 7240005

    Málaga, 29015, Spain

  • Investigational Site Number : 7240007

    Seville, 41014, Spain

  • Investigational Site Number : 7240014

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240018

    Madrid, 28660, Spain

  • J. Lewis Research Site Number : 8400017

    Salt Lake City, Utah, 84109, United States

  • JBR Clinical Research Site Number : 8400001

    Salt Lake City, Utah, 84107, United States

  • Kentucky Pediatrics / Adult Research Site Number : 8400010

    Bardstown, Kentucky, 40004, United States

  • Meridian Clinical Research Site Number : 8400006

    Binghamton, New York, 13905, United States

  • Meridian Clinical Research- Sioux City Site Number : 8400007

    Sioux City, Iowa, 51106, United States

  • Ohio Pediatric Research Site Number : 8400020

    Dayton, Ohio, 45414, United States

  • Rainbow Pediatrics Site Number : 8400014

    Barnwell, South Carolina, 29812, United States

  • The Children's Clinic Of Jonesboro PA Site Number : 8400025

    Jonesboro, Arkansas, 72401, United States

  • Velocity Clinical Research Lincoln Site Number : 8400013

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research Omaha Site Number : 8400009

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research Vestal Site Number : 8400016

    Vestal, New York, 13850, United States

  • Velocity Clinical Research- New Orleans Site Number : 8400012

    New Orleans, Louisiana, 70119, United States

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Other studies related to the condition(s) this trial covers.