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A Multi-Center, Observer-Blind, Randomized, Phase 3 Study to Evaluate Safety, Non-Inferiority of Multi-Dose and Single-Dose Vial Formulations of EuTCV (Vi-CRM197 Typhoid Conjugate Vaccine) and Lot-to-Lot Consistency of the Immune Response to Multi-Dose Vial Formulation EuTCV in Healthy Participants in Kenya and Senegal
19 Pages Posted: 24 Jan 2025
More...Abstract
A randomized, active-controlled, observer-blind, phase 3 study was conducted in healthy African adults and children to evaluate the safety, immune responses, and lot-to-lot consistency of EuTCV in single-dose and multi-dose presentations to support WHO prequalification. 3129 participants randomly received a single dose of either single-dose EuTCV, multi-dose EuTCV, and Typbar TCV®. Infants aged 9-12 months received TCV co-administered with yellow fever and measles-rubella vaccines. Safety was assessed through monitoring anaphylactic reactions, adverse events for 28 days, and serious adverse events over 180 days. Immunogenicity was assessed using validated ELISAs for anti-Salmonella typhi Vi IgG, Measles and rubella IgG and the plaque reduction neutralisation test (PRNT50 ). EuTCV was safe and well-tolerated. EuTCV was immunologically non-inferior to Typbar TCV® at 28 days after vaccination and also across lots. The seroconversion rates were over 98% for all the TCVs. When co-administered with measles-rubella and yellow fever vaccines, immune responses are maintained with seroconversion rates maintained above 95%, 86% and 95% respectively. Pan-African Clinical Trials Registry identifier, PACTR202112680671189.
Keywords: Africa, Kenya, Senegal, EuTCV, Typhoid, adults, children, infants, conjugate vaccine, safety, immunogenicity, intramuscular.
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