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

Primary Purpose

Meningitis, Meningococcal

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Experimental Group A meningococcal polysaccharide vaccine
Control Group A meningococcal polysaccharide vaccine
Sponsored by
Wei Cun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal

Eligibility Criteria

6 Months - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers
  • 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. Participants 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.
  • 3-17 years group:

    • Inclusion Criteria

      1. Healthy volunteer aged 3 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 and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
      6. Immunization with any vaccine within 30 days.
      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. Women with positive pregnancy test after menarche.
      16. Any other situations judged by investigators as not suitable for participating in this study.
  • 6-15 months group:

    • Inclusion Criteria

      1. Healthy infants aged 6 to 15 months.
      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 meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
      5. Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birth weight < 2300g for girls and < 2500g for boys);
      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 infants aged 6 to 15 months.
    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 meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
    5. Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birth weight < 2300g for girls and < 2500g for boys);
    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.

Sites / Locations

  • Yunnan Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Vaccine

Active Comparator Vaccine

Arm Description

Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12

Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12

Outcomes

Primary Outcome Measures

Seroconversion rate
Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after the second vaccination

Secondary Outcome Measures

Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Serious adverse events
Occurence of Serious adverse events after vaccination
GMT
GMT of Group A meningococcal bactericidal antibody at day 28 after the second vaccination

Full Information

First Posted
December 8, 2020
Last Updated
December 28, 2020
Sponsor
Wei Cun
Collaborators
Yunnan Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04689165
Brief Title
A Phase III Clinical Trial of the Group A Meningococcal Polysaccharide Vaccine
Official Title
A Randomized, Double-Blind, Controlled, Non-inferiority Phase III Trial of a Group A Meningococcal Polysaccharide Vaccine in Healthy Infants Aged 6-15 Months
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Cun
Collaborators
Yunnan Center for Disease Control and Prevention

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
This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 6-15 months.
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 3-17 years, and 40 subjects aged 6-15 months. The second phase was a randomized, double-blind, controlled, non-inferiority phase III clinical trial in 1200 healthy infants aged 6-15 months, to evaluate the immunogenicity and safety of the experimental vaccine after two doses of immunization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Vaccine
Arm Type
Experimental
Arm Description
Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
Arm Title
Active Comparator Vaccine
Arm Type
Active Comparator
Arm Description
Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
Intervention Type
Biological
Intervention Name(s)
Experimental Group A meningococcal polysaccharide vaccine
Intervention Description
Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
Intervention Type
Biological
Intervention Name(s)
Control Group A meningococcal polysaccharide vaccine
Intervention Description
Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
Primary Outcome Measure Information:
Title
Seroconversion rate
Description
Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after the second vaccination
Time Frame
28 days after the second vaccination
Secondary Outcome Measure Information:
Title
Adverse reactions/events rate
Description
Occurence of adverse reactions/events after vaccination
Time Frame
7 days after vaccination
Title
Adverse reactions/events rate
Description
Occurence of adverse reactions/events after vaccination
Time Frame
28 days after vaccination
Title
Serious adverse events
Description
Occurence of Serious adverse events after vaccination
Time Frame
6 months after the second vaccination
Title
GMT
Description
GMT of Group A meningococcal bactericidal antibody at day 28 after the second vaccination
Time Frame
28 days after the second vaccination
Other Pre-specified Outcome Measures:
Title
Seroconversion rate
Description
Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after the first vaccination
Time Frame
28 days after the first vaccination
Title
GMT
Description
GMT of Group A meningococcal bactericidal antibody at day 28 after the first vaccination
Time Frame
28 days after the first vaccination
Title
Seroconversion rate
Description
Seroconversion rate of Group A meningococcal bactericidal antibody at 3 months after the first vaccination
Time Frame
3 months after the first vaccination
Title
GMT
Description
GMT of Group A meningococcal bactericidal antibody at 3 months after the first vaccination
Time Frame
3 months after the first vaccination
Title
Seropositive rate
Description
Seropositive rate of Neutralizing antibody against EV71 at day 28 after the second vaccination
Time Frame
28 days after the second vaccination
Title
GMT of Neutralizing antibody against EV71
Description
GMT of Neutralizing antibody against EV71 at day 28 after the second vaccination
Time Frame
28 days after the second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The First stage study (An early safety assessment study): 18-50 years group: Inclusion Criteria Healthy adults aged 18 to 50 years. Proven legal identity. 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. Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial. Axillary temperature ≤37.0℃. Exclusion Criteria: Contraindications for vaccination. History of allergy to vaccines or drugs. History of Epidemic Cerebrospinal Meningitis. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years. Immunization with any vaccine within 30 days. Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy. 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. Those who developed acute disease or acute attack of chronic disease. Surgical removal of spleen or other important organs for any reason. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection. Blood products such as immunoglobulin were received within 30 days before vaccination. 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). Those who participated in other clinical studies. 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. Any other situations judged by investigators as not suitable for participating in this study. 3-17 years group: Inclusion Criteria Healthy volunteer aged 3 to 17 years. Proven legal identity. 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. Participants and their legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial. Axillary temperature ≤37.0℃. Exclusion Criteria: Contraindications for vaccination. History of allergy to vaccines or drugs. History of Epidemic Cerebrospinal Meningitis. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months. Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years. Immunization with any vaccine within 30 days. Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy. 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. Those who developed acute disease or acute attack of chronic disease. Surgical removal of spleen or other important organs for any reason. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection. Blood products such as immunoglobulin were received within 30 days before vaccination. 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). Those who participated in other clinical studies. Women with positive pregnancy test after menarche. Any other situations judged by investigators as not suitable for participating in this study. 6-15 months group: Inclusion Criteria Healthy infants aged 6 to 15 months. Proven legal identity. 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. Participants' legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial. Axillary temperature ≤37.0℃. Exclusion Criteria: Contraindications for vaccination. History of allergy to vaccines or drugs. History of Epidemic Cerebrospinal Meningitis. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months. Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birth weight < 2300g for girls and < 2500g for boys); 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); Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy. 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. Those who developed acute disease or acute attack of chronic disease. Surgical removal of spleen or other important organs for any reason. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection. Blood products such as immunoglobulin were received within 30 days before vaccination. 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). Those who participated in other clinical studies. 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 Healthy infants aged 6 to 15 months. Proven legal identity. 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. Participants' legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial. Axillary temperature ≤37.0℃. Exclusion Criteria: Contraindications for vaccination. History of allergy to vaccines or drugs. History of Epidemic Cerebrospinal Meningitis. Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months. Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birth weight < 2300g for girls and < 2500g for boys); 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); Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy. 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. Those who developed acute disease or acute attack of chronic disease. Surgical removal of spleen or other important organs for any reason. History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection. Blood products such as immunoglobulin were received within 30 days before vaccination. 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). Those who participated in other clinical studies. Any other situations judged by investigators as not suitable for participating in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Cun, Doctor
Phone
+86-13629464497
Email
cunwei@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zheng, Master
Organizational Affiliation
Yunnan Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yunnan Center for Disease Control and Prevention
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Cun, Doctor
Phone
+86-13629464497
Email
cunwei@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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