A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain

Background: In resource-poor settings, cold chain requirements present barriers for vaccine delivery. We evaluated the immunogenicity and safety of tetanus toxoid (TT) vaccine in “Controlled Temperature Chain” (CTC; up to 40 °C for <30 days before administration), compared to standard cold chain (SCC; 2–8 °C). Prior to the study, stability parameters of TT–CTC were shown to meet international requirements. Methods: A cluster randomized, non-inferiority trial was conducted in Moïssala district, Chad, December 2012–March 2013. Thirty-four included clusters were randomized to CTC or SCC. Women aged 14–49 years, eligible for TT vaccination and with a history of ≤1 TT dose, received two TT doses 4 weeks apart. Participants were blinded to allocation strategy. Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations (GMC). Non-inferiori

Added by: Dan Brigden
Added on: 14 August, 2015
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