Randomized, double-blind comparison of standard-dose vs. high-dose trivalent inactivated influenza vaccine in paediatric solid organ transplant patients
GiaQuinta S, Michaels MG, et al.Pediatric Transplantation 2015: 19: 219-228.
Aims
To compare standard-dose (SD) versus high-dose (HD) trivalent inactivated influenza vaccine in paediatric solid organ transplant patients.
Interventions
Patients were randomized to receive 0.5 mL of either the HD (60 µg) or SD (15 µg) trivalent inactivated influenza vaccine (TIV) intramuscularly. Subjects <9 yr. of age received either one or two doses of the vaccine based on the Advisory Committee on Immunization Practices (ACIP) recommendations.
Participants
38 paediatric patients between the ages of three and seventeen.
Outcomes
The primary outcome measures were safety and the frequency of solicited local and systemic reactogenicity, adverse events, and serious adverse events. The secondary outcome measures were immunogenicity and the comparison of the geometric mean titer of hemagglutination inhibition titers, percent of children who develop hemagglutination inhibition antibody titers ≥1:40, and percent of children who develop seroconversion.
Follow-up
180 days
CET Conclusions
This is an important phase I study comparing vaccination with high dose trivalent inactivated influenza vaccine to a standard dose vaccine in paediatric patients between 3-17 years of age and at least 6 months after a solid organ transplant. 38 paediatric recipients were enrolled with a mean age of 11.25 years and were recipients of heart, liver, lung and intestinal transplants, the majority being renal, heart and liver. No severe adverse events were reported and in particular there was no evidence of rejection occurring after vaccination. There were more local symptoms in the high dose group and more systemic symptoms again in the high dose group. However there was a much higher percentage of a significant rise in titre in the high dose group compared to the standard dose group, against H3N2. The authors conclude that the high dose vaccine was well tolerated and may have increased in immunogenicity and recommend that a larger phase II study be carried out.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT01525004