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

A Randomized, Blinded, Comparable Vaccine-controlled Phase IIIb Clinical Trial to Evaluate the Safety and Immunogenicity of Meningococcal Polysaccharide Conjugate Vaccine, Group ACYW135 (CRM197 Vector), in a 4 to 6 Year-old Population

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Epidemic Meningitis
• Intervention / Treatment: Biological: MCV4; Biological: MSPV4

Detailed Description

The preventive measures for influenza are based on strengthening personal protection, vaccination, strengthening surveillance, early detection of patients, and active isolation and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants under 2 years of age, and only a transient immune response is produced. Numerous experiments have shown that the immunogenicity of polysaccharides is enhanced by binding to protein carriers, and a significant booster effect is produced. Meningococcal polysaccharide conjugate vaccine induces a good immune response in infants and children under 2 years of age and produces immune memory, which enhances the immune effect of the vaccine and can eliminate the carrier state of infected patients.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shupeng Zhang; Phone Number: 022-58213600-6051; Email: shupeng.zhang@cansinotech.com
• Study Contact Backup: Name: Weijun Hu; Phone Number: 029-82221350; Email: huwj0828@163.com

Study Locations

• China
  • Shanxi
    • Shanyang, Shanxi, China
      • Shanyang County Center for Disease Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4); Intramuscular injection, 0.5ml	Biological: MCV4; 1 dose of MCV4 on Day 0
Active Comparator: ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4); Subcutaneous injection, 0.5ml	Biological: MSPV4; 1 dose of MSPV4 on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects	90 and 180 days of exemption
Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects	90 and 180 days of exemption
Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects	Within 180 days of exemption
All subjects were stratified into susceptible (<1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold	30 days after immunization

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; CRM197; ACYW135; 4~6 yearsof age
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Neuroinflammatory Diseases; Meningitis, Meningococcal; Meningitis
• Other Study ID Numbers: CTP-MCVF-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No