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

July 2, 2025 updated by: CanSino Biologics Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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
Time Frame: 30 days after immunization
30 days after immunization
Incidence of adverse reactions within 30 minutes after immunization in all subjects
Time Frame: Within 30 minutes after immunization
Within 30 minutes after immunization
Incidence of adverse reactions/events within 7 days of immunization for all subjects
Time Frame: Within 7 days after immunization
Within 7 days after immunization
Incidence of adverse reactions/events within 30 days of exemption for all subjects
Time Frame: Within 30 days of exemption
Within 30 days of exemption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization
Time Frame: 30 days after immunization
30 days after immunization
Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization
Time Frame: 30 days after immunization
30 days after immunization
Antibody titers ≥1:128 ratio for all subjects 30 days after immunization
Time Frame: 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
Time Frame: 90 and 180 days of exemption
90 and 180 days of exemption
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
90 and 180 days of exemption
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
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
Time Frame: 90 and 180 days of exemption
90 and 180 days of exemption
Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects
Time Frame: Within 180 days of exemption
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
Time Frame: 30 days after immunization
30 days after immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CanSino Biologics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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