MenQuadfi's Phase 3 Trial in Meningococcal Infection Reads Out
推定確度 50%ClinicalTrials.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). Telephone calls (TCs) are planned on the 4th, the 9th, and the 21st day after each vaccination, and 5 TCs (1 TC/month) are planned for the 5 m
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