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

NCT06226714 | Active Not Recruiting Phase 3

• 1 other identifier: CTP-MCVF-003
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 3

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

Keywords

Vaccine; Peer controlled; Immunogenicity; Safety; 18-59 years

Outcome Measures

Primary Outcomes (5)

• Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects

  30 days post immunization

• Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects

  30 days post immunization

• Incidence of adverse reactions in all subjects

  Within 30 mins after immunization

• Incidence of adverse reactions/events in all subjects

  7 days post immunization

• Incidence of adverse reactions/events in all subjects

  Within 30 days after immunization

Secondary Outcomes (9)

• Meningococcal antibody positivity for groups A, C, Y, and W135

  30 days post immunization

• Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135

  30 days post immunization

• Antibody titer ≥1:128 ratio for groups A, C, Y, and W135

  30 days post 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

Study Arms (2)

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

EXPERIMENTAL

Intramuscular injection, 0.5ml

Biological: MCV4

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

ACTIVE COMPARATOR

Subcutaneous iniection, 0.5ml

Biological: MPSV4

Interventions

MCV4 BIOLOGICAL

1 dose of MCV4 on Day 0

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

MPSV4 BIOLOGICAL

1 dose of MSPV4 on Day 0

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (3)

Jiangjin District Center for Disease Control and Prevention

Chongqing, China

Location

Wanzhou District Center for Disease Control and Prevention

Chongqing, China

Location

Yuzhong District Center for Disease Control and Prevention

Chongqing, China

Location

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Qing Wang

  Chongqing Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: March 1, 2024
• Primary Completion: September 26, 2024
• Study Completion: August 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-03

Locations

CN (3)