Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07374510
PHASE1

Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

Sponsor: Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-01-21

Completion Date

2026-11-30

Last Updated

2026-01-28

Healthy Volunteers

Yes

Interventions

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