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

NCT06700148 | Active Not Recruiting Phase 3

• 1 other identifier: CTP-MCVF-010
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 2

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

Keywords

Vaccine; Peer controlled; Immunogenicity; Safety; 7-17 years

Outcome Measures

Primary Outcomes (5)

• 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 7 days after immunization

• Incidence of adverse reactions/events in all subjects

  Within 30 days after immunization

Secondary Outcomes (8)

• 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

Study Arms (2)

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

EXPERIMENTAL

Biological: MCV4

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

ACTIVE COMPARATOR

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 MPSV4 on Day0

ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (2)

Dengfeng Center for Disease Control and Prevention

Dengfeng, China

Location

Kaifeng Center for Disease Control and Prevention

Kaifeng, 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

• Zhiqiang Xie

  Henan 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: November 19, 2024
• First Posted: November 21, 2024
• Study Start: December 14, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 29, 2025

Record last verified: 2024-11

Locations

CN (2)