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

NCT ID: NCT06700148

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-14
• Study Completion Date: 2025-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4)

Group Type: EXPERIMENTAL

MCV4

Intervention Type: BIOLOGICAL

1 dose of MCV4 on Day 0

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

Group Type: ACTIVE_COMPARATOR

MPSV4

Intervention Type: BIOLOGICAL

1 dose of MPSV4 on Day0

Interventions

MCV4

1 dose of MCV4 on Day 0

Intervention Type: BIOLOGICAL

MPSV4

1 dose of MPSV4 on Day0

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiqiang Xie

Role: PRINCIPAL_INVESTIGATOR

Henan Center for Disease Control and Prevention

Locations

Dengfeng Center for Disease Control and Prevention

Dengfeng, , China

Kaifeng Center for Disease Control and Prevention

Kaifeng, , China

Countries

China

Other Identifiers

CTP-MCVF-010

Identifier Type: -

Identifier Source: org_study_id