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

Primary Purpose

Epidemic Meningitis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
MCV4
MCV4
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epidemic Meningitis focused on measuring ACYW135, CRM197, Immunogenicity, Persistence, 6~23 months of age

Eligibility Criteria

6 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wuzhi County Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vaccine Group A

Vaccine Group B

Arm Description

2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)

2 dose of (MCV4) (0.5ml)

Outcomes

Primary Outcome Measures

Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption

Secondary Outcome Measures

Antibody positivity for A, C, Y and W135 in all subjects 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
A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 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

Full Information

First Posted
June 27, 2023
Last Updated
September 25, 2023
Sponsor
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05935176
Brief Title
Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
Official Title
Phase IV Clinical Trial of Immunogenicity of ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 6 to 23 Months
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
ACYW135 group meningococcal polysaccharide conjugate vaccine produced by Conchino Biologicals JSC is a covalent coupling conjugate of purified meningococcal podococcal polysaccharide of groups A, C, Y and W135 with CRM197 protein of diphtheria bacillus non-virulent mutant. The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidemic Meningitis
Keywords
ACYW135, CRM197, Immunogenicity, Persistence, 6~23 months of age

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccine Group A
Arm Type
Experimental
Arm Description
2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)
Arm Title
Vaccine Group B
Arm Type
Experimental
Arm Description
2 dose of (MCV4) (0.5ml)
Intervention Type
Biological
Intervention Name(s)
MCV4
Intervention Description
2 dose of MCV4 on Day 0 and Month 1
Intervention Type
Biological
Intervention Name(s)
MCV4
Intervention Description
2 dose of MCV4 on Day 0 and Month 3
Primary Outcome Measure Information:
Title
Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption
Time Frame
6 months after 2 dose exemption
Secondary Outcome Measure Information:
Title
Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption
Time Frame
9 months after 2 dose exemption
Title
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
Time Frame
30 days after dose 2 exemption
Title
A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption
Time Frame
6 and 9 months after 2 dose exemption
Title
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
Time Frame
30 days , 60 days after the first dose, and before the second dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuting Li
Phone
022-58213600-6051
Email
shuting.li@cansinotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Huang
Email
13643826177@163.com
Facility Information:
Facility Name
Wuzhi County Center for Disease Control and Prevention
City
Jiaozuo
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueli Li
Email
wzxlxl6278@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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