drugset / Trial / NCT06337071

A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

NCT06337071 ↗

Phase 2 Unknown 1200 enrolled Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.

Timeline

Start
2024-03-20
Primary completion
2024-06
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ACYW135 Meningococcal Polysaccharide Conjugate Vaccine Vaccine — —
Comparator ACYW135 Meningococcal Polysaccharide Vaccine Vaccine — —