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NCT05947071 · ClinicalTrials.gov registry record · Phase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
A Phase 2 study of Influenza and Immunization; Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
- 8
- Study locations
NCT05947071 is a Phase 2 study of Influenza and Immunization; Infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 312 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 8 study locations across 8 states.
The verdict
NCT05947071, a Phase 2 study of Influenza and Immunization; Infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Standard Dose Quadrivalent Inactivated Influenza Vaccine
- BIOLOGICAL High Dose Quadrivalent Inactivated Influenza Vaccine
Study Locations (8)
California
- Stanford University - Stanford
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann Robert H. Lurie Children's Hospital of Chicago - Chicago
Missouri
- Children's Mercy Hospital - Kansas City
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Tennessee
- Monroe Carell Jr. Children's Hospital at Vanderbilt - Nashville
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05947071
The ClinicalTrials.gov registry entry for NCT05947071 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Standard Dose Quadrivalent Inactivated Influenza Vaccine is the first listed.
NCT05947071 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT05947071 about?
NCT05947071 is a clinical study titled "High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients". 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...
What is the current status of trial NCT05947071?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2024-09-26. Estimated completion is 2027-09-01.
What conditions does trial NCT05947071 study?
This clinical trial studies the following conditions: Influenza, Immunization; Infection, Transplantation Infection.
What interventions are being tested in trial NCT05947071?
The interventions under investigation include: Standard Dose Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL), High Dose Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05947071?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05947071 being conducted?
This trial has 8 study locations across California, Georgia, Illinois, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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