Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
Phase 1
- Conditions
- Meningitis, Meningococcal
- Interventions
- Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
- Registration Number
- NCT02878291
- Lead Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- 3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
- Subject or legal representative who consent and has signed written informed consent.
- Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- Subject and parent/guardian who is able to comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Exclusion Criteria
- History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- Allergic history after vaccination.
- History of meningitis infection disease.
- Acute Febrile illness and Infectious Diseases.
- Febrile illness (temperature ≥ 38°C) in the 3 days.
- Immunodeficiency diseases patients who administered with immunosuppressive agents.
- Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.
- Liver and kidney or cardiopulmonary disease，acute hypertension and diabetes.
- In pregnancy or lactation or pregnant women.
- Subject who plan to participate in or is in any other drug clinical trial.
- Meningococcal vaccine contraindication.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose Group Meningococcal ACYW135 Polysaccharide Conjugate Vaccine Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose low dose Group Meningococcal ACYW135 Polysaccharide Conjugate Vaccine Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose
- Primary Outcome Measures
Name Time Method Occurrence of adverse events during a 30 day follow-up period after each vaccination 30 day after each vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanjiang Center for Disease Control and Prevention
🇨🇳Sanjiang, Guangxi, China