A multicenter, single-blind, randomized, phase-2/3 study to evaluate immunogenicity and safety of a single intramuscular dose of biological E's Vi-capsular polysaccharide-CRM₁₉₇ conjugate typhoid vaccine (TyphiBEV^TM) in healthy infants, children, and adults in comparison with a licensed comparator.

ABSTRACT: The current scenario of typhoid fever warrants early prevention with typhoid conjugate vaccines in susceptible populations to provide lifelong protection. We conducted a multicenter, single-blind, randomized, Phase 2/3 study to assess the immunogenicity and safety of Biological E's Typhoid Vi-CRM₁₉₇ conjugate vaccine (TyphiBEV^TM) compared to Vi-TT conjugate vaccine manufactured by Bharat Biotech International Limited (Typbar-TCV; licensed comparator) in healthy infants, children, and adults from India. The study's primary objective was to assess the non-inferiority of TyphiBEV^TM in terms of the difference in the proportion of subjects seroconverted with a seroconversion threshold value of ≥2.0 µg/mL against Typbar-TCV. A total of 622 healthy subjects (311 e

SUBMITTER: Thuluva S 

PROVIDER: S-EPMC9196756 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature