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

NCT ID: NCT05935176

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2025-01-08

Brief Summary

ACYW135 group meningococcal polysaccharide conjugate vaccine produced by Conchino Biologicals JSC is a covalent coupling conjugate of purified meningococcal podococcal polysaccharide of groups A, C, Y and W135 with CRM197 protein of diphtheria bacillus non-virulent mutant. The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).

Detailed Description

Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).

Conditions

Epidemic Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaccine Group A

2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)

Group Type: EXPERIMENTAL

MCV4

Intervention Type: BIOLOGICAL

2 dose of MCV4 on Day 0 and Month 1

Vaccine Group B

2 dose of (MCV4) (0.5ml)

Group Type: EXPERIMENTAL

MCV4

Intervention Type: BIOLOGICAL

2 dose of MCV4 on Day 0 and Month 3

Interventions

MCV4

2 dose of MCV4 on Day 0 and Month 1

Intervention Type: BIOLOGICAL

MCV4

2 dose of MCV4 on Day 0 and Month 3

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Children aged 6 to 23 months at the time of screening
• Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination
• The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol

Exclusion Criteria

• Fever before inoculation, axillary temperature >37.0℃
• History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history
• During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode)
• Known allergy to a component of the vaccine, especially to diphtheria toxoid
• Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment
• Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
• Those who had a severe allergic reaction after the previous dose of vaccine
• Those with serious adverse reactions causally related to the previous dose of vaccination

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuzhi County Center for Disease Control and Prevention

Jiaozuo, Henan, China

Countries

China

Other Identifiers

CTP-MCVF-004

Identifier Type: -

Identifier Source: org_study_id