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A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

NCT06700148 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2025-07-29

No results posted yet for this study

Summary

This is a randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups, afterwards some subjects entered the immune persistence group.

Conditions

  • Meningococcal Meningitis

Interventions

BIOLOGICAL

MCV4

1 dose of MCV4 on Day 0

BIOLOGICAL

MPSV4

1 dose of MPSV4 on Day0

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Zhiqiang Xie · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-14
Primary Completion
2025-08-30
Completion
2025-08-30

Countries

  • China

Study Locations

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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 NCT06700148 on ClinicalTrials.gov