Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.

Inclusion Criteria:

• 2 years old and above healthy people.
• Subject or legal representative who consent and has signed written informed consent.
• Subject or legal representative who is able to comply with all study procedures.
• Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
• Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

• History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
• Allergic history after vaccination.
• Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer）
• Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
• Known immunological impairment or dysfunction.
• Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
• Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
• Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
• In pregnancy or lactation or pregnant women.
• Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
• Any contraindications that investigators consider related to vaccination.