Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

Phase IV Clinical Trial of Immunogenicity of ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 6 to 23 Months

The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).

Study Overview

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

Detailed Description

Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Jiaozuo, Henan, China
      • Wuzhi County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

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

Description

Part Ⅰ

Inclusion Criteria:

• Children aged 6 to 23 months at the time of screening
• Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination
• 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℃
• History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history
• During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode)
• Known allergy to a component of the vaccine, especially to diphtheria toxoid
• Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment
• Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
• Those who had a severe allergic reaction after the previous dose of vaccine
• Those with serious adverse reactions causally related to the previous dose of vaccination
• Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the exclusion criteria for the first dose will be determined by the investigator whether to continue to participate in the study

Part Ⅱ

Inclusion Criteria:

• The first phase of the study has been completed, involving the (0, 3) month vaccination schedule group for subjects aged 6 to 11 months. All subjects received two doses as required, and blood samples were collected 30 days after the primary vaccination series.
• Children aged 3 years at the time of screening
• The trial participant is able and willing to comply with the requirements of the clinical trial protocol and can complete the 1-month study follow-up.
• The trial participants did not receive any meningococcal vaccine booster doses at age 3 years
• The legal guardian or authorized representative voluntarily signs the informed consent form with full knowledge and understanding, and is able to comply with the requirements of the clinical research protocol.

Exclusion Criteria:

• Fever prior to vaccination, with axillary temperature >37.0°C
• History of epilepsy, convulsions, or seizures; psychiatric history or family history of psychiatric disorders
• During acute phase of illness; severe chronic disease or progressive condition not well controlled (or in acute phase)
• Known allergy to any vaccine component, particularly diphtheria toxoid
• Receipt of live attenuated vaccines within 14 days or other vaccines within 7 days prior to enrollment
• Other conditions deemed ineligible for this clinical study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part Ⅰ: Vaccine Group A; 2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)	Biological: MCV4; 2 dose of MCV4 on Day 0 and Month 1; Biological: MCV4; 2 dose of MCV4 on Day 0 and Month 3; Biological: MCV4; 1 booster dose of MCV4 at 3 years old
Experimental: PartⅠ: Vaccine Group B; 2 dose of MCV4 (0.5ml)	Biological: MCV4; 2 dose of MCV4 on Day 0 and Month 1; Biological: MCV4; 2 dose of MCV4 on Day 0 and Month 3; Biological: MCV4; 1 booster dose of MCV4 at 3 years old
Experimental: Part Ⅱ: Vaccine Group C; 1 dose of MCV4 (0.5ml) at 3 years old from group B in Part I	Biological: MCV4; 2 dose of MCV4 on Day 0 and Month 1; Biological: MCV4; 2 dose of MCV4 on Day 0 and Month 3; Biological: MCV4; 1 booster dose of MCV4 at 3 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption	6 months after 2 dose exemption
Seroconversion rates for serotypes A, C, Y, and W135	30 days post-booster vaccination
Geometric mean titers (GMTs) for serotypes A, C, Y, and W135	30 days post-booster vaccination
Increased incidence of adverse reactions	Within 7 days after post-booster vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption	9 months after 2 dose exemption
A, C, Y and W135 antibody positive conversion rate, positivity rate, GMT, GMI, ≥1:128 ratio in all subjects at 30 days after dose 2 exemption	30 days after dose 2 exemption
A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption	6 and 9 months after 2 dose exemption
A, C, Y and W135 antibody GMT, positivity rate, GMI 30 days, 60 days after the first dose, and before the second dose in some subjects of the (0, 3) month immunization program	30 days , 60 days after the first dose, and before the second dose
Increased incidence of adverse events	Within 7 days after post-booster vaccination
Increased Incidence of adverse reactions/events	Within 30 days after post-booster vaccination
A, C, Y, and W135 Antibody Positivity Rates and GMI and ≥1:128 Proportions	Within 30 days after post-booster vaccination

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Immunogenicity; Persistence; CRM197; ACYW135; 6~23 months of age; 3 years old
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Central Nervous System Infections; Neisseriaceae Infections; Meningitis; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Meningitis, Meningococcal
• Other Study ID Numbers: CTP-MCVF-004

Drug and device information, study documents

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