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

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.