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

Last updated: December 28, 2020
Sponsor: Wei Cun
Overall Status: Active - Recruiting

Phase

3

Condition

Meningitis

Treatment

N/A

Clinical Study ID

NCT04689165
20190701
  • Ages 6-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

  • 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, andbe capable of using thermometers, scales, and filling in diary cards andcontact 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

  • 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 orpolysaccharide vaccine within 12 months.
  5. Immunization with any Group A and C meningococcal conjugate vaccine orpolysaccharide vaccine within 3 years.
  6. Immunization with any vaccine within 30 days.
  7. Participants with convulsion, epilepsy, encephalopathy and psychiatrichistory or family history of epilepsy.
  8. History of abnormal clinical manifestations and serious diseases to beexcluded, including but not limited to nervous system, cardiovascularsystem, blood and lymphatic system, immune system, kidney, liver,gastrointestinal tract, respiratory system, metabolism, bones and othersystem 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 causecontraindication of subcutaneous injection.
  12. Blood products such as immunoglobulin were received within 30 days beforevaccination.
  13. Have received immunosuppressive therapy or other immunomodulatory drugswithin 6 months before signing the informed consent form (Note: inhaled ortopical hormone drugs, except those with an interval of 14 days or more fromthe 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, orplan to become pregnant, or plan to donate sperm or eggs from the screeningto 12 months after the second vaccination.
  16. Any other situations judged by investigators as not suitable forparticipating 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 theinformed consent form, the vaccine in this trial, voluntarily sign theinformed consent form, and be capable of using thermometers, scales, andfilling in diary cards and contact cards as required.
  4. Participants and their legal guardians should be able to communicate wellwith investigators, understand and comply with the requirements of thistrial.
  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 orpolysaccharide vaccine within 12 months.
  5. Immunization with any Group A and C meningococcal conjugate vaccine orpolysaccharide vaccine within 3 years.
  6. Immunization with any vaccine within 30 days.
  7. Participants with convulsion, epilepsy, encephalopathy and psychiatrichistory or family history of epilepsy.
  8. Participant who has congenital heart disease, congenital malformation,Down's syndrome, sickle cell anemia or severe diseases with previousclinical manifestations that need to be excluded, including but not limitedto 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 bonesystem 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 causecontraindication of subcutaneous injection.
  12. Blood products such as immunoglobulin were received within 30 days beforevaccination.
  13. Have received immunosuppressive therapy or other immunomodulatory drugswithin 6 months before signing the informed consent form (Note: inhaled ortopical hormone drugs, except those with an interval of 14 days or more fromthe 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 forparticipating 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 informedconsent form, the vaccine in this trial, voluntarily sign the informedconsent form, and be capable of using thermometers, scales, and filling indiary cards and contact cards as required.
  4. Participants' legal guardians should be able to communicate well withinvestigators, 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 orpolysaccharide 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 beforevaccination and subunit or inactivated vaccine within 7 days (copy ofvaccination certificate of subjects);
  7. Participants with convulsion, epilepsy, encephalopathy and psychiatrichistory or family history of epilepsy.
  8. Participant who has congenital heart disease, congenital malformation,Down's syndrome, sickle cell anemia or severe diseases with previousclinical manifestations that need to be excluded, including but not limitedto 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 bonesystem 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 causecontraindication of subcutaneous injection.
  12. Blood products such as immunoglobulin were received within 30 days beforevaccination.
  13. Have received immunosuppressive therapy or other immunomodulatory drugswithin 6 months before signing the informed consent form (Note: inhaled ortopical hormone drugs, except those with an interval of 14 days or more fromthe 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 forparticipating 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 informedconsent form, the vaccine in this trial, voluntarily sign the informed consentform, and be capable of using thermometers, scales, and filling in diary cardsand contact cards as required.
  4. Participants' legal guardians should be able to communicate well withinvestigators, 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 polysaccharidevaccine within 12 months.
  5. Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birthweight < 2300g for girls and < 2500g for boys);
  6. They were vaccinated with live attenuated vaccine within 14 days beforevaccination and subunit or inactivated vaccine within 7 days (copy of vaccinationcertificate of subjects);
  7. Participants with convulsion, epilepsy, encephalopathy and psychiatric history orfamily history of epilepsy.
  8. Participant who has congenital heart disease, congenital malformation, Down'ssyndrome, sickle cell anemia or severe diseases with previous clinicalmanifestations that need to be excluded, including but not limited to nervoussystem, genetic defect disease (such as faba bean disease), cardiovascularsystem, 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 causecontraindication of subcutaneous injection.
  12. Blood products such as immunoglobulin were received within 30 days beforevaccination.
  13. Have received immunosuppressive therapy or other immunomodulatory drugs within 6months before signing the informed consent form (Note: inhaled or topical hormonedrugs, except those with an interval of 14 days or more from the date of signingthe informed consent form).
  14. Those who participated in other clinical studies.
  15. Any other situations judged by investigators as not suitable for participating inthis study.

Study Design

Total Participants: 1280
Study Start date:
September 14, 2020
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Yunnan Center for Disease Control and Prevention

    Kunming, Yunnan
    China

    Active - Recruiting

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