drugset / Trial / NCT07374510

Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

NCT07374510

Phase 1 Not yet recruiting 150 enrolled Sinovac Life Sciences Co., Ltd.
RandomizedSequentialQuadruple-blindPrevention

Summary

This trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. This study is planned to enroll 150 participants in total, with healthy individuals aged 2 to 59 years as participants. Among them, participants aged 18 to 59 years and 7 to 17 years will be assigned to the open-label design arm, while participants aged 4 to 6 years will be assigned to the randomized, blinded, placebo-controlled design arms.

Timeline

Start
2026-01-21
Primary completion
2026-09-10
Completion
2026-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) Vaccine
Subject Group ACYW135X Meningococcal Conjugate Vaccine Vaccine