Endpoints
ADVERSE EVENTS
The primary safety endpoints were the frequencies and incidences of serious adverse events (SAEs) throughout the study, unsolicited adverse events (AE), especially those graded as severe during the 28 days following study vaccination and solicited reactogenicity (local and systemic reactions) during the 7 days following vaccination and challenge. The primary efficacy endpoint, the proportion of participants without detectable fecal shedding of bOPV vaccine viruses in the IPV + dmLT and IPV arms, 7 days after challenge, was chosen as a direct measure of the intestinal immunity conferred by vaccination.Secondary endpoints included the proportions of participants with type-specific poliovirus fecal IgA and neutralizing responses 28 days after vaccination and 14 days after challenge; the serum neutralizing antibody (NAb) seroconversion rate and NAb levels 28 days after vaccination with IPV + dmLT or IPV; the area under the curve (AUC) of fecal shedding measured by CCID