MenQuadfi's Phase 3 Trial in Meningococcal Infection Reads Out
ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidenceClinicalTrials.gov[1] lists 2028-03-13 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Sanofi's phase 3 trial of MenQuadfi in meningococcal infection reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 4,568 participants. The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China. Study details include: * Study duration (including 6-month safety follow-up after the last dose): * Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months) * Cohort II (Groups 3 and 4): up to 18 months * Cohort III (Groups 5 and 6): up to 21 months * Cohort III (Group 7): approximately 16 months * Vaccination Visits Period: * Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121).