A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine

December 28, 2020 updated by: Wei Cun

A Randomized, Double-Blind, Controlled, Non-inferiority Phase III Trial of a Group A and C Meningococcal Polysaccharide Vaccine in Healthy Children Aged 2-6 Years

This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A and C meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 2-6 years.

Study Overview

Status

Status

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

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

This study was divided into two stages. The first stage study was an early safety assessment study among 80 subjects. The first stage study was conducted gradually in 20 subjects aged 18-50 years, 20 subjects aged 7-17 years, and 40 subjects aged 2-6 years. The second phase was a randomized, double-blind, controlled, non-inferiority phase III clinical trial in 1200 healthy infants aged 2-6 years, to evaluate the immunogenicity and safety of the experimantal vaccine after immunization.

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 (Anticipated)

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.
1280

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 Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan 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

2 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • The First stage study (An early safety assessment study):

  • 18-50 years group:

    • Inclusion Criteria:

      1. Healthy adults aged 18 to 50 years.
      2. Proven legal identity.
      3. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
      4. Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
      5. Axillary temperature ≤37.0℃.

    • Exclusion Criteria:

      1. Contraindications for vaccination.
      2. History of allergy to vaccines or drugs.
      3. History of Epidemic Cerebrospinal Meningitis.
      4. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
      5. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
      6. Immunization with any vaccine within 30 days.
      7. Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
      8. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
      9. Those who developed acute disease or acute attack of chronic disease.
      10. Surgical removal of spleen or other important organs for any reason.
      11. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
      12. Blood products such as immunoglobulin were received within 30 days before vaccination.
      13. Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
      14. Those who participated in other clinical studies.
      15. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 12 months after the second vaccination.
      16. Any other situations judged by investigators as not suitable for participating in this study.

  • 7-17 years group:

    • Inclusion Criteria

      1. Healthy volunteer aged 7 to 17 years.
      2. Proven legal identity.
      3. Participants and their legal guardians should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
      4. Participants and their legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial.
      5. Axillary temperature ≤37.0℃.

    • Exclusion Criteria:

      1. Contraindications for vaccination.
      2. History of allergy to vaccines or drugs.
      3. History of Epidemic Cerebrospinal Meningitis.
      4. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
      5. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
      6. Immunization with any vaccine within 30 days.
      7. Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
      8. Participant who has congenital heart disease, congenital malformation, Down's syndrome, sickle cell anemia or severe diseases with previous clinical manifestations that need to be excluded, including but not limited to nervous system, genetic defect disease (such as faba bean disease), cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases, and History of malignant tumor.
      9. Those who developed acute disease or acute attack of chronic disease.
      10. Surgical removal of spleen or other important organs for any reason.
      11. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
      12. Blood products such as immunoglobulin were received within 30 days before vaccination.
      13. Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
      14. Those who participated in other clinical studies.
      15. Women with positive pregnancy test after menarche.
      16. Any other situations judged by investigators as not suitable for participating in this study.

  • 2-6 years group:

    • Inclusion Criteria

      1. Healthy children aged 2 to 6 years.
      2. Proven legal identity.
      3. Participants' legal guardians should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
      4. Participants' legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial.
      5. Axillary temperature ≤37.0℃.

    • Exclusion Criteria:

      1. Contraindications for vaccination.
      2. History of allergy to vaccines or drugs.
      3. History of Epidemic Cerebrospinal Meningitis.
      4. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine.
      5. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
      6. They were vaccinated with live attenuated vaccine within 14 days before vaccination and subunit or inactivated vaccine within 7 days (copy of vaccination certificate of subjects);
      7. Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
      8. Participant who has congenital heart disease, congenital malformation, Down's syndrome, sickle cell anemia or severe diseases with previous clinical manifestations that need to be excluded, including but not limited to nervous system, genetic defect disease (such as faba bean disease), cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases, and History of malignant tumor.
      9. Those who developed acute disease or acute attack of chronic disease.
      10. Surgical removal of spleen or other important organs for any reason.
      11. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
      12. Blood products such as immunoglobulin were received within 30 days before vaccination.
      13. Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
      14. Those who participated in other clinical studies.
      15. Any other situations judged by investigators as not suitable for participating in this study.

The Second stage study (A phase III clinical trial )

  • Inclusion Criteria

    1. Healthy children aged 2 to 6 years.
    2. Proven legal identity.
    3. Participants' legal guardians should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
    4. Participants' legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial.
    5. Axillary temperature ≤37.0℃.

  • Exclusion Criteria:

    1. Contraindications for vaccination.
    2. History of allergy to vaccines or drugs.
    3. History of Epidemic Cerebrospinal Meningitis.
    4. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine.
    5. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
    6. They were vaccinated with live attenuated vaccine within 14 days before vaccination and subunit or inactivated vaccine within 7 days (copy of vaccination certificate of subjects);
    7. Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
    8. Participant who has congenital heart disease, congenital malformation, Down's syndrome, sickle cell anemia or severe diseases with previous clinical manifestations that need to be excluded, including but not limited to nervous system, genetic defect disease (such as faba bean disease), cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases, and History of malignant tumor.
    9. Those who developed acute disease or acute attack of chronic disease.
    10. Surgical removal of spleen or other important organs for any reason.
    11. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
    12. Blood products such as immunoglobulin were received within 30 days before vaccination.
    13. Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
    14. Those who participated in other clinical studies.
    15. Any other situations judged by investigators as not suitable for participating in this study.

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: Experimental Vaccine
One dose of Experimental Group A and C meningococcal polysaccharide vaccine
Biological: Experimental Group A and C meningococcal polysaccharide vaccine
One dose of Experimental Group A and C meningococcal polysaccharide vaccine
Active Comparator: Active Comparator Vaccine
One dose of Control Group A and C meningococcal polysaccharide vaccine
Biological: Control Group A and C meningococcal polysaccharide vaccine
One dose of Control Group A and C meningococcal polysaccharide vaccine

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
Measure Description
Time Frame
Seroconversion rate of Group A meningococcal bactericidal antibody
Time Frame: 28 days after vaccination
Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after vaccination
28 days after vaccination
Seroconversion rate of Group C meningococcal bactericidal antibody
Time Frame: 28 days after vaccination
Seroconversion rate of Group C meningococcal bactericidal antibody at day 28 after vaccination
28 days after vaccination

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
Measure Description
Time Frame
Adverse reactions/events rate
Time Frame: 7 days after vaccination
Occurence of adverse reactions/events after vaccination
7 days after vaccination
Adverse reactions/events rate
Time Frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
28 days after vaccination
Serious adverse events
Time Frame: 6 months after the second vaccination
Occurence of Serious adverse events after vaccination
6 months after the second vaccination
GMT of Group A meningococcal bactericidal antibody
Time Frame: 28 days after the second vaccination
GMT of Group A meningococcal bactericidal antibody at day 28 after the second vaccination
28 days after the second vaccination
GMT of Group C meningococcal bactericidal antibody
Time Frame: 28 days after the second vaccination
GMT of Group C meningococcal bactericidal antibody at day 28 after the second vaccination
28 days after the second vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GMT of IgG antibody against Hepatitis A
Time Frame: 28 days after the second vaccination
GMT of IgG antibody against Hepatitis A at day 28 after vaccination
28 days after the second vaccination
Seropositive rate of IgG antibody against Hepatitis A
Time Frame: 28 days after the second vaccination
Seropositive rate of IgG antibody against Hepatitis A at day 28 after vaccination
28 days after the second vaccination

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.
Wei Cun

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yunnan Center for Disease Control and Prevention

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: Yan Zheng, Mater, Yunnan 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.
September 15, 2020

Primary Completion (Anticipated)

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.
May 1, 2021

Study Completion (Anticipated)

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.
December 1, 2021

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).
December 8, 2020

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.
December 28, 2020

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.
December 30, 2020

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.
December 30, 2020

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.
December 28, 2020

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.
December 1, 2020

More Information

Terms related to this study

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.
  • 20190702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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