A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine
NCT ID: NCT04689191
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1280 participants
INTERVENTIONAL
2020-09-15
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental Vaccine
One dose of Experimental Group A and C meningococcal polysaccharide vaccine
Experimental Group A and C meningococcal polysaccharide vaccine
One dose of Experimental Group A and C meningococcal polysaccharide vaccine
Active Comparator Vaccine
One dose of Control Group A and C meningococcal polysaccharide vaccine
Control Group A and C meningococcal polysaccharide vaccine
One dose of Control Group A and C meningococcal polysaccharide vaccine
Interventions
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Experimental Group A and C meningococcal polysaccharide vaccine
One dose of Experimental Group A and C meningococcal polysaccharide vaccine
Control Group A and C meningococcal polysaccharide vaccine
One dose of Control Group A and C meningococcal polysaccharide vaccine
Eligibility Criteria
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Inclusion Criteria
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℃.
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℃.
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℃.
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
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:
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:
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 )
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.
2 Years
50 Years
ALL
Yes
Sponsors
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Yunnan Center for Disease Control and Prevention
OTHER
Wei Cun
UNKNOWN
Responsible Party
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Wei Cun
Professor
Principal Investigators
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Yan Zheng, Mater
Role: PRINCIPAL_INVESTIGATOR
Yunnan Center for Disease Control and Prevention
Locations
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Yunnan Center for Disease Control and Prevention
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Wei Cun, Doctor
Role: primary
Other Identifiers
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20190702
Identifier Type: -
Identifier Source: org_study_id