High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jul 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to vaccinate children who have received solid organ transplants, like kidneys, hearts, or livers, to protect them from the flu. The researchers want to find out if giving two doses of a high-dose flu vaccine will help these young patients have a better immune response compared to two doses of the standard flu vaccine. This is important because children who have had transplants often don't respond well to the regular vaccine.

To be eligible for this study, children aged 3 to 17 who are between 1 and 24 months post-transplant can participate. If you choose to enroll, you can expect to receive either two doses of the high-dose flu vaccine or two doses of the standard vaccine. The study is currently recruiting participants, and they will be closely monitored to ensure safety and effectiveness. It's also important to know that there are some health conditions that would exclude someone from participating, such as severe allergies to the vaccine or certain medical histories.

Gender

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Eligibility criteria

• 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.