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

Primary Purpose

Epidemic Meningitis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MCV4
MSPV4
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, Safety, 4~6 yearsof age

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanyang County Center for Disease Prevention and ControlRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)

Arm Description

Intramuscular injection, 0.5ml

Subcutaneous injection, 0.5ml

Outcomes

Primary Outcome Measures

Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
Incidence of adverse reactions within 30 minutes after immunization in all subjects
Incidence of adverse reactions/events within 7 days of immunization for all subjects
Incidence of adverse reactions/events within 30 days of exemption for all subjects

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2023
Last Updated
September 25, 2023
Sponsor
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06011200
Brief Title
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (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
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.
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.

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, Safety, 4~6 yearsof age

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)
Arm Type
Experimental
Arm Description
Intramuscular injection, 0.5ml
Arm Title
ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)
Arm Type
Active Comparator
Arm Description
Subcutaneous injection, 0.5ml
Intervention Type
Biological
Intervention Name(s)
MCV4
Intervention Description
1 dose of MCV4 on Day 0
Intervention Type
Biological
Intervention Name(s)
MSPV4
Intervention Description
1 dose of MSPV4 on Day 0
Primary Outcome Measure Information:
Title
Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
Time Frame
30 days after immunization
Title
Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
Time Frame
30 days after immunization
Title
Incidence of adverse reactions within 30 minutes after immunization in all subjects
Time Frame
Within 30 minutes after immunization
Title
Incidence of adverse reactions/events within 7 days of immunization for all subjects
Time Frame
Within 7 days after immunization
Title
Incidence of adverse reactions/events within 30 days of exemption for all subjects
Time Frame
Within 30 days of exemption
Secondary Outcome Measure Information:
Title
Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization
Time Frame
30 days after immunization
Title
Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization
Time Frame
30 days after immunization
Title
Antibody titers ≥1:128 ratio for all subjects 30 days after immunization
Time Frame
30 days after immunization
Title
Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time Frame
90 and 180 days of exemption
Title
GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time Frame
90 and 180 days of exemption
Title
GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time Frame
90 and 180 days of exemption
Title
Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
Time Frame
90 and 180 days of exemption
Title
Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects
Time Frame
Within 180 days of exemption
Title
All subjects were stratified into susceptible (<1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold
Time Frame
30 days after immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shupeng Zhang
Phone
022-58213600-6051
Email
shupeng.zhang@cansinotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weijun Hu
Phone
029-82221350
Email
huwj0828@163.com
Facility Information:
Facility Name
Shanyang County Center for Disease Prevention and Control
City
Shanyang
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Zhang
Email
401924434@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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