Phase 3 efficacy analysis of a typhoid conjugate vaccine trial in Nepal
New England Journal of Medicine Dec 12, 2019
Shakya M, Colin-Jones R, Theiss-Nyland K, et al. - Researchers investigated the efficacy of a typhoid conjugate vaccine (TCV) in areas where typhoid is endemic. They performed a phase 3, randomized, controlled trial in Lalitpur, Nepal, in which youth between 9 months and 16 years of age were randomized in a 1:1 ratio to receive either a TCV or a capsular group A meningococcal conjugate vaccine (MenA; control). TCV was provided to 10,005 participants and the MenA vaccine was provided to 10,014. In 7 participants who received TCV (79 cases per 100,000 person-years) and in 38 who received MenA vaccine (428 cases per 100,000 person-years), blood culture-confirmed typhoid fever occurred. The occurrence of 132 serious adverse events was reported (61 in the TCV group and 71 in the MenA vaccine group). Overall, the authors’ findings supported the immunogenicity and effectiveness of a single dose of TCV in decreasing Salmonella Typhi bacteremia in children 9 months to 16 years of age.
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