Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Influenza and Immunization; Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Antibody titers will be measured by hemagglutination inhibition assay.
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 |
What NCT05947071 shows while recruiting
NCT05947071 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05947071's enrollment target sits among peer trials
312 64th of 156 higher than 93 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
RECRUITING · Phase 2
-
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
RECRUITING · Phase 2
-
Systems Investigation of Vaccine Responses in Aging and Frailty
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients
ACTIVE NOT RECRUITING · Phase 2
-
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04984551 · 312 participants · Phase 2
Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
- NCT04999904 · 312 participants · NA
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
- NCT05220332 · 312 participants · NA
Church-based Intervention to Improve Blood Pressure in African Americans
- NCT05434234 · 312 participants · Phase 1
A Study of YL201 in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI