Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months

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.