Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.
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Safety of PCV13i in preventing pneumococcal infections
Timeframe: Within 7 days post each vaccination
Safety of PCV13i in preventing pneumococcal infections
Timeframe: Within 30 days post each vaccination
Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Timeframe: 30 days post three doses
Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)
Timeframe: 30 days post three doses
Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)
Timeframe: 30 days post last dose of vaccination
Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
Timeframe: 30 days post vaccination