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

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: Unknown
• Conditions: Meningitis, Meningococcal
• Intervention / Treatment: Biological: Experimental Group A and C meningococcal polysaccharide vaccine; Biological: Control Group A and C meningococcal polysaccharide vaccine

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: Interventional
• Enrollment (Anticipated): 1280
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Yunnan Center For Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT of IgG antibody against Hepatitis A	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	Seropositive rate of IgG antibody against Hepatitis A at day 28 after vaccination	28 days after the second vaccination

Collaborators and Investigators

• Sponsor: Wei Cun
• Collaborators: Yunnan Center for Disease Control and Prevention
• Investigators: Principal Investigator: Yan Zheng, Mater, Yunnan Center For Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID 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