Actively Recruiting
Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-21
312
Participants Needed
8
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pediatric solid organ transplant (SOT) recipients face challenges with influenza virus infections, as they typically have weaker responses to the standard-dose (SD) inactivated influenza vaccine (IIV). Previous studies in adults and small pediatric groups suggest high-dose (HD) IIV or two doses of SD-IIV may improve immune responses, but these have not been tested extensively in children within 24 months post-transplant. This trial aims to determine if two doses of HD quadrivalent inactivated influenza vaccine (QIV) are safe and generate stronger immune responses than two doses of SD-QIV in this vulnerable pediatric population. This phase II, multi-center, double-blind randomized trial will compare two doses of SD-QIV (0.5 mL; 15bcg of each influenza antigen) against two doses of HD-QIV (0.7 mL; 60bcg of each influenza antigen) given 28 to 42 days apart. Approximately 312 pediatric heart, liver, and kidney transplant recipients between 1 and 23 months post-transplant will be enrolled and randomized to one of the two vaccine groups. Active influenza surveillance will monitor symptoms and nasal swabs will be collected before and after vaccination during the influenza season. Participants will undergo safety monitoring for local and systemic reactions within 7 days after each vaccine dose and have blood drawn to measure immune response four weeks after the second dose. Additional assessments include antibody levels after each dose and durability of response 180 days post second vaccination. Weekly communication during influenza season will track illness symptoms. Participation is expected to last through the vaccination and follow-up periods to evaluate vaccine safety and immune response in these pediatric transplant recipients.
CONDITIONS
Brief 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 between 1 month and less than 24 months post-transplant at study immunization
- Recipients of multiple organs including kidney, heart, and/or liver are permitted
- Participants undergoing re-transplantation are permitted
- Anticipated availability for study duration
- Access to telephone, email, or text message communication
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 within 24 months prior to enrollment
- Received current season's influenza vaccine post-transplant before enrollment
- Currently pregnant or lactating (urine pregnancy test required before each vaccine dose)
- Other medical or laboratory conditions that increase risk or interfere with study participation as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 8 weeks
Participants receive two doses of either the high dose or standard dose influenza vaccine 28 to 42 days apart.
2 vaccination visits (in-person)
Duration - Up to the length of the influenza season following vaccination, up to approximately 6 months
Participants are actively monitored for influenza-like symptoms during the influenza season, including weekly telephone or electronic contacts and nasal swabs at main visits to document influenza virus occurrence.
Weekly contacts during influenza season and nasal swabs at main visits
Duration - Up to 6 months post vaccination
Participants are followed to assess immunogenicity and safety outcomes, including evaluation of immune response 4 weeks after each vaccine dose and durability of immune response up to 180 days after the second vaccine dose.
Approximately 3 to 4 follow-up visits (in-person)
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
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