NCT07374510

Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

An Open-Label Combined Randomized, Blinded, Placebo- and Active-Controlled Phase Ia Clinical Trial: Evaluate the Safety and Immunogenicity of the Group ACYW135X Meningococcal Conjugate Vaccine in Individuals Aged 2 to 59 Years

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	high-dose Group ACYW135X Meningococcal Conjugate Vaccine	high-dose Group ACYW135X Meningococcal Conjugate Vaccine
BIOLOGICAL	medium-dose Group ACYW135X Meningococcal Conjugate Vaccine	medium-dose Group ACYW135X Meningococcal Conjugate Vaccine
BIOLOGICAL	low-dose Group ACYW135X Meningococcal Conjugate Vaccine	low-dose Group ACYW135X Meningococcal Conjugate Vaccine
BIOLOGICAL	Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)	Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
BIOLOGICAL	Placebo	placebo

Timeline

• Start date: 2026-01-21
• Primary completion: 2026-09-10
• Completion: 2026-11-30
• First posted: 2026-01-28
• Last updated: 2026-01-28