Actively Recruiting
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-21
312
Participants Needed
8
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 3-17 years of age at time of enrollment
- Pediatric kidney, heart, and/or liver transplant recipient 1 month to less than 24 months post-transplant at time of immunization
- Recipients of multiple organs including kidney, heart, and/or liver are permitted
- Participants undergoing re-transplantation are permitted
- Anticipated to be available for the duration of the study
- Available by telephone, email, or text message
You will not qualify if you...
- Unable or unwilling to provide informed consent or comply with study protocol
- History of severe hypersensitivity to influenza vaccine or anaphylaxis to eggs/egg protein
- History of severe latex hypersensitivity
- History of Guillain-Barre syndrome
- History of lung or intestine transplant
- HIV positive (tested within 24 months of enrollment)
- Received current season's influenza vaccine post-transplant prior to enrollment
- Currently pregnant or lactating (pregnancy test required prior to each vaccine for females of childbearing age)
- Any other medical problems or findings that may increase risk or interfere with study participation or data quality as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Ann Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
4
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
7
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here