A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

NCT ID: NCT06226714

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: 2024-03-01
• Study Completion Date: 2025-08-31

Brief Summary

This is a randomized, observer-blind, 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.

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)

Intramuscular injection, 0.5ml

Group Type: EXPERIMENTAL

MCV4

Intervention Type: BIOLOGICAL

1 dose of MCV4 on Day 0

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

Subcutaneous iniection, 0.5ml

Group Type: ACTIVE_COMPARATOR

MPSV4

Intervention Type: BIOLOGICAL

1 dose of MSPV4 on Day 0

Interventions

MCV4

1 dose of MCV4 on Day 0

Intervention Type: BIOLOGICAL

MPSV4

1 dose of MSPV4 on Day 0

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 18~59 years old at the time of screening.
• Should not have received any meningococcal vaccine in the last 3 years.
• Volunteers 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 the 180-day study follow-up visit.
• Volunteers 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 the 180-day study follow-up visit.
• Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Exclusion Criteria

• Fever before vaccination, axillary temperature >37.0°C.
• History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
• Volunteers with current meningitis or a history of meningitis.
• Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
• Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
• Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
• Previous vaccination-related hospitalizations or emergencies.
• Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
• Other vaccinations within 14 days.
• Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
• Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Wang

Role: PRINCIPAL_INVESTIGATOR

Chongqing Center for Disease Control and Prevention

Locations

Jiangjin District Center for Disease Control and Prevention

Chongqing, , China

Wanzhou District Center for Disease Control and Prevention

Chongqing, , China

Yuzhong District Center for Disease Control and Prevention

Chongqing, , China

Countries

China

Other Identifiers

CTP-MCVF-003

Identifier Type: -

Identifier Source: org_study_id