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MinorStudy sites: 8 to 10Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 3 entries · Study description expanded, about 6 wordsShow 3 more changesShow less
Eligibility criteria expanded, about 15 words
Secondary endpoints: details revised at 1 of 3 entries
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Sep 15, 2024 to Sep 26, 2024 · Site details revised at 8 of 8 sitesv6Show 2 more changesShow less
Start date changed from estimate of Sep 15, 2024 to Sep 26, 2024
Site details revised at 8 of 8 sites
NotableStart date: Aug 1, 2024 to Sep 15, 2024v5
MinorRe-verified, no change to tracked fieldsv4
NotableLead sponsor: Vanderbilt University Medical Center to National Institute of Allergy and Infectious Diseases (NIAID)Primary completion date: Jul 2028 to Jul 1, 2027 · Start date: Nov 2023 to Aug 1, 2024 · Study sites: 1 to 8 · 5 morev3Show 8 more changesShow less
Primary completion date: Jul 2028 to Jul 1, 2027
Start date: Nov 2023 to Aug 1, 2024
Study sites: 1 to 8
Completion date: Dec 2028 to Sep 1, 2027
Eligibility criteria shortened, about 91 words
Secondary endpoints: details revised at 1 of 3 entries
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.
The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.