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

A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7-17 Year Olds

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Meningococcal Meningitis
• Intervention / Treatment: Biological: MCV4; Biological: MPSV4

• Study Type: Interventional
• Enrollment (Actual): 840
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Dengfeng, China
    • Dengfeng Center for Disease Control and Prevention
  • Kaifeng, China
    • Kaifeng Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 7~17 years old at the time of screening
• Volunteers and their legal guardians or delegates have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete 180 days of study follow-up
• Willingness to discuss medical history with the investigator or physician and to allow access to all medical records related to this trial

Exclusion Criteria:

• Fever on the day of vaccination, axillary temperature >37.0°C
• Have a moderate or severe acute illness/infection
• Positive urine pregnancy test for females of childbearing age, or plan to become pregnant within 30 days after vaccination
• Current meningitis or history of meningitis
• Allergy to certain components or excipients of the drugs used in this clinical trial (mainly including: group A meningococcal podoplanoside, group C meningococcal podoplanoside, group Y meningococcal podoplanoside, group W135 meningococcal podoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate)
• History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
• Previous severe allergic reactions due to drugs or vaccines
• Bleeding constitution or condition associated with prolonged bleeding, which in the opinion of the investigator makes intramuscular injection contraindicated
• Any meningococcal vaccine in the last 1 year
• Any other vaccine within 14 days
• Participation in other studies involving interventional studies within 28 days (<28 days) prior to study entry and/or during study participation
• Other conditions that, in the judgment of the investigator, make participation in this clinical trial unsuitable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4)	Biological: MCV4; 1 dose of MCV4 on Day 0
Active Comparator: ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)	Biological: MPSV4; 1 dose of MPSV4 on Day0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse reactions in all subjects	Within 30 mins after immunization
Incidence of adverse reactions/events in all subjects	Within 30 days after immunization
Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects	30 Days After Immunization
Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects	30 Days after immunization
Incidence of adverse reactions/events in all subjects	Within 7 days after immunization

Secondary Outcome Measures

Outcome Measure	Time Frame
Meningococcal antibody positivity for groups A, C, Y, and W135	30 days after immunization
Geometric mean multiplicity of increase (GMI) for groups A, C, Y, and W135	30 days after immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135	30 days after immunization
Meningococcal Antibody Positivity for Groups A, C, Y, and W135 in Selected Subjects	180 days after immunization
GMT for Groups A, C, Y, and W135 in Selected Subjects	180 days after immunization
GMI for Groups A, C, Y, and W135 in Selected Subjects	180 days after immunization
Antibody Titer ≥1:128 Ratio for Groups A, C, Y, and W135 in Selected Subjects	180 days after immunization
Incidence of Serious Adverse Events (SAEs) for all subjects	Within 180 days after immunization

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Investigators: Principal Investigator: Zhiqiang Xie, Henan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Peer controlled; 7-17 years
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Central Nervous System Infections; Neisseriaceae Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Meningitis; Meningitis, Meningococcal
• Other Study ID Numbers: CTP-MCVF-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No