Comparing high and standard dose influenza vaccines in pediatric organ transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, multi-center, double-blind, randomized controlled trial aims to evaluate the immunogenicity and safety of high-dose quadrivalent inactivated influenza vaccine (HD-QIV) versus standard-dose quadrivalent inactivated influenza vaccine (SD-QIV) in pediatric solid organ transplant (SOT) recipients. The study will enroll approximately 312 participants aged 3-17 years who are between 1 and 23 months post-transplant. Participants will receive two doses of either HD-QIV or SD-QIV, and the primary outcome will be the comparison of Hemagglutination Inhibition (HAI) geometric mean titers between the two groups. The study will also assess the safety profile of the vaccines and explore correlations between baseline immunophenotypic markers and post-vaccine immune responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Stanford University
  Stanford, California, United States Recruiting
• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Ann Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Indiana University School of Medicine/Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting
• Children's Mercy Hospital
  Kansas City, Missouri, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.