Meningitis, Meningococcal
Conditions
Brief summary
The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months
Interventions
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
Sponsors
Guangxi Center for Disease Control and Prevention
Sanjiang Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Air Force Military Medical University, China
Simoon Record Pharma Information Consulting Co., Ltd.
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination |
Countries
China
Outcome results
None listed