Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.

Inclusion Criteria:

• 2 months old (at a minimum of 6 weeks old) and above healthy people.
• Subject or legal representative who consent and has signed written informed consent.
• Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required.
• Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine.
• Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
• Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

• Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae.
• Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination.
• Subject who are allergic to diphtheria toxins.
• Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight <2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis.
• History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
• Subject who diagnosis of thrombocytopenia or other history of coagulopathy.
• 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: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period.
• Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc.
• Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization).
• Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.).
• In pregnancy or lactation or pregnant women.
• ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities.
• Any condition that, in the judgment of investigator, may affect trial assessment.