Status:
UNKNOWN
A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine
Lead Sponsor:
Wei Cun
Collaborating Sponsors:
Yunnan Center for Disease Control and Prevention
Conditions:
Meningitis, Meningococcal
Eligibility:
All Genders
2-50 years
Phase:
PHASE3
Brief Summary
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 i...
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 ...
Eligibility Criteria
Inclusion
- The First stage study (An early safety assessment study):
- 18-50 years group:
- 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
- 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.
- Patients 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.
- 7-17 years group:
- Inclusion Criteria
- Healthy volunteer aged 7 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℃.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT04689191
Start Date
September 15 2020
End Date
December 1 2021
Last Update
December 30 2020
Active Locations (1)
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1
Yunnan Center for Disease Control and Prevention
Kunming, Yunnan, China