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Could a Double-Dose flu vaccine better protect transplant kids?

NCT ID NCT05947071

Vaccine Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a high-dose flu vaccine to the standard dose in 312 children aged 3-17 who have received a kidney, heart, or liver transplant within the past two years. The goal is to see if the high-dose vaccine triggers a stronger immune response and is just as safe. Participants will receive two doses of either vaccine, one month apart.

What this could mean

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

Active substance
Influenza vaccine (high-dose or standard-dose quadrivalent inactivated)
What this could lead to
If successful, this could show that a high-dose flu vaccine provides better protection for children with organ transplants, reducing flu-related complications.
What could go wrong
This is a phase 2 trial with 312 participants, so results are still early. The high-dose vaccine may not prove more effective or could cause more side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Male or female, 3-17 years of age at time of enrollment 2. Pediatric kidney, heart, and/or liver transplant recipient ≥1 month and \<24 months post-transplant at the time of study immunization * Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and/or liver * Note: Participants undergoing re-transplantation are permitted 3. Anticipated to be available for duration of the study 4. Available by telephone, email, or text message Exclusion Criteria: 1. Inability (i.e. not able to understand and provide consent) or unwillingness of a participant/parent/legal guardian to give written informed consent or comply with study protocol 2. History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein 3. History of severe latex hypersensitivity 4. History of Guillain-Barre syndrome 5. History of lung or intestine transplant 6. HIV positive patients (testing within 24 months of enrollment) 7. Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study 8. Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine) 9. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

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Conditions

The condition(s) this trial relates to.

disease related to transplantation Infections infectious disease influenza prevention target

As listed by the trial registrant

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

Immunization; infection Influenza Transplantation infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ann Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60614, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

More trials for these conditions

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