NCT02878291UnknownPhase 1
A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd1 site in 1 country200 target enrollmentStarted: June 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Occurrence of adverse events during a 30 day follow-up period after each vaccination
Study Overview
Brief Summary
The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
High dose Group
Experimental
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose
Intervention: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine (Biological)
low dose Group
Experimental
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose
Intervention: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine (Biological)
Outcomes
Primary Outcomes
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time Frame: 30 day after each vaccination
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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