A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population

NCT06011200 | Completed Phase 3

• 1 other identifier: CTP-MCVF-002
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics worldwide, the main clinical features of its infection are fever, rash and meningitis, the most common clinical manifestation is acute bacterial meningitis.

Conditions

Epidemic Meningitis

Keywords

ACYW135; CRM197; Immunogenicity; Safety; 4~6 yearsof age

Outcome Measures

Primary Outcomes (5)

• Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization

  30 days after immunization

• Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization

  30 days after immunization

• Incidence of adverse reactions within 30 minutes after immunization in all subjects

  Within 30 minutes after immunization

• Incidence of adverse reactions/events within 7 days of immunization for all subjects

  Within 7 days after immunization

• Incidence of adverse reactions/events within 30 days of exemption for all subjects

  Within 30 days of exemption

Secondary Outcomes (9)

• Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization

  30 days after immunization

• Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization

  30 days after immunization

• Antibody titers ≥1:128 ratio for all subjects 30 days after immunization

  30 days after immunization

• Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects

  90 and 180 days of exemption

• GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects

  90 and 180 days of exemption

Study Arms (2)

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

EXPERIMENTAL

Intramuscular injection, 0.5ml

Biological: MCV4

ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)

ACTIVE COMPARATOR

Subcutaneous injection, 0.5ml

Biological: MSPV4

Interventions

MCV4 BIOLOGICAL

1 dose of MCV4 on Day 0

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

MSPV4 BIOLOGICAL

1 dose of MSPV4 on Day 0

ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4\~6 years old
• Complete at least two doses of basic immunization with polysaccharide influenza vaccine according to the immunization program
• The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol

You may not qualify if:

• Fever before inoculation, axillary temperature \>37.0℃
• Previous history of immunization with meningococcal polysaccharide conjugate vaccine
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• History of epilepsy, convulsions or seizures or a history of psychiatric illness or family history
• Volunteers with current meningitis or a history of meningitis
• Volunteers treated with immunosuppressive therapy, cytotoxic therapy, glucocorticoids (excluding topical treatment, surface treatment for acute uncomplicated dermatitis, spray treatment for allergic rhinitis) within the past 6 months (\<6 months)
• Received blood/plasma products or immunoglobulins within 60 days (\<60 days) prior to study vaccination or planned to receive blood/plasma products or immunoglobulins throughout the study period
• Suffering from serious chronic diseases or conditions that are in a progressive stage and cannot be controlled smoothly, such as thyroid disease
• Volunteers with known or suspected diseases that are judged by the investigator to affect vaccination such as severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, severe liver or kidney disease, malignancy, severe infectious or allergic skin disease
• History of serious adverse reactions associated with the vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the investigational vaccine
• Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., malignancy, HIV, etc.)
• Bleeding constitution or condition associated with prolonged bleeding, investigators consider intramuscular injection to be contraindicated
• Live attenuated vaccine given within 14 days, other vaccines given within 7 days
• Participation in other studies involving interventions within 28 days (\<28 days) prior to study entry and/or during study participation
• Other conditions judged by the investigator to be inappropriate for participation in this clinical trial

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Shanyang County Center for Disease Prevention and Control

Shanyang, Shaanxi, 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 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: August 15, 2023
• First Posted: August 25, 2023
• Study Start: September 16, 2023
• Primary Completion: December 11, 2023
• Study Completion: May 11, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-03

Locations

CN (1)