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

Phase 3

Active, not recruiting

• Conditions: Meningococcal Meningitis
• Interventions: Biological: MCV4; Biological: MPSV4

• Registration Number: NCT06700148
• Lead Sponsor: CanSino Biologics Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Study Start: 2024-12-14
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 840

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4)	MCV4	-
ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)	MPSV4	-

Primary Outcome Measures

Name	Time	Method
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 in all subjects	Within 30 mins after immunization
Incidence of adverse reactions/events in all subjects	Within 30 days after immunization

Secondary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAEs) for all subjects	Within 180 days after immunization
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

Trial Locations

Locations (2)

Kaifeng Center for Disease Control and Prevention; 🇨🇳 Kaifeng, China

Dengfeng Center for Disease Control and Prevention; 🇨🇳 Dengfeng, China