A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

July 28, 2025 updated by: CanSino Biologics Inc.

A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 18-59 Years

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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.
840

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 Locations

  • China
      • Chongqing, China
        • Jiangjin District Center for Disease Control and Prevention
      • Chongqing, China
        • Wanzhou District Center for Disease Control and Prevention
      • Chongqing, China
        • Yuzhong District Center for Disease Control and Prevention

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18~59 years old at the time of screening.
  • Should not have received any meningococcal vaccine in the last 3 years.
  • Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
  • Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
  • Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Exclusion Criteria:

  • Fever before vaccination, axillary temperature >37.0°C.
  • History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
  • Volunteers with current meningitis or a history of meningitis.
  • Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
  • Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
  • Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
  • Previous vaccination-related hospitalizations or emergencies.
  • Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
  • Other vaccinations within 14 days.
  • Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
  • Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

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 (MPSV4)
Subcutaneous iniection, 0.5ml
Biological: MPSV4
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
Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects
Time Frame: 30 days post immunization
30 days post immunization
Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects
Time Frame: 30 days post immunization
30 days post immunization
Incidence of adverse reactions in all subjects
Time Frame: Within 30 mins after immunization
Within 30 mins after immunization
Incidence of adverse reactions/events in all subjects
Time Frame: 7 days post immunization
7 days post immunization
Incidence of adverse reactions/events in all subjects
Time Frame: Within 30 days after immunization
Within 30 days after immunization

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 antibody positivity for groups A, C, Y, and W135
Time Frame: 30 days post immunization
30 days post immunization
Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135
Time Frame: 30 days post immunization
30 days post immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135
Time Frame: 30 days post immunization
30 days post immunization
Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects
Time Frame: 180 days after immunization
180 days after immunization
GMT for groups A, C, Y, and W135 in selected subjects
Time Frame: 180 days after immunization
180 days after immunization
GMI for groups A, C, Y, and W135 in selected subjects
Time Frame: 180 days after immunization
180 days after immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects
Time Frame: 180 days after immunization
180 days after immunization
Incidence of serious adverse events (SAEs) in all subjects
Time Frame: Within 180 days after immunization
Within 180 days after immunization
Incidence of pregnancy events in all subjects
Time Frame: Within 180 days after immunization
Within 180 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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qing Wang, Chongqing Center for Disease Control and Prevention

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.
March 1, 2024

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.
September 26, 2024

Study Completion (Estimated)

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.
August 1, 2025

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).
January 18, 2024

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.
January 18, 2024

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.
January 26, 2024

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 29, 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 28, 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-003

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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