Pediatric Infectious Disease Journal:
POST ACCEPTANCE, 10 February 2012
doi: 10.1097/INF.0b013e31824e2924
Vaccine Reports: PDF Only
A Randomized, Controlled Trial in Children to Assess the Immunogenicity and Safety of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine
Domachowske, Joseph B. MD; Blatter, Mark MD; Chandrasekaran, Vijayalakshmi MS; Liu, Aixue MD, PhD; Jain, Varsha K. MD, MPH; Fries, Louis MD
Background: Children are at high risk of acquiring and transmitting influenza infection and are a high priority group for influenza vaccination.
Methods: This was a randomized, observer-blind, multicenter study (NCT00980005) based in the US. Children were randomized (1:1) to receive either the study vaccine, a thimerosal-free trivalent inactivated influenza vaccine, or an active comparator (control vaccine) and were allotted to one of 3 age categories: 3-4, 5-8 and 9-17 years. The primary objective was to show non-inferiority of the study vaccine versus a US licensed control influenza vaccine.
Results: 2116 children were vaccinated (study vaccine N=1055, control vaccine N=1061). The predefined non-inferiority criteria and the Center for Biologics Evaluation and Research (CBER) criteria for clinical benefit were met for all three seasonal virus strains in all children and each age strata. The ratios of the adjusted geometric mean titers (GMTs; control vaccine over study vaccine) ranged from 0.93-1.03 for the three virus strains while the differences in seroconversion rate (SCR; control vaccine minus study vaccine) were between -2.42% and -1.60%. Post-vaccination GMTs (range: 213.7-414.7 vs. 200.2-451.9) and SCRs (range: 59.8-81.1% vs. 58.2-78.6%) were comparable for the two vaccines. The safety and reactogenicity profiles were similar for both treatment groups in all age strata.
Conclusions: Immunologic non-inferiority of the study vaccine was demonstrated compared with the control vaccine. Furthermore, the study vaccine had a similar safety profile as the control vaccine in children.
(C) 2012 Lippincott Williams & Wilkins, Inc.
