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Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

NCT05935176 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2026-03-04

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).

Conditions

  • Epidemic Meningitis

Interventions

BIOLOGICAL

MCV4

2 dose of MCV4 on Day 0 and Month 1

BIOLOGICAL

MCV4

2 dose of MCV4 on Day 0 and Month 3

BIOLOGICAL

MCV4

1 booster dose of MCV4 at 3 years old

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2026-05-15
Completion
2026-07-15

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 NCT05935176 on ClinicalTrials.gov