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Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

NCT07374510 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374510 on ClinicalTrials.gov