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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
237
0.5mL,Intramuscular other name:PCV13i
0.5mL,Intramuscular other name:Prevnar
Neihuang Center for Disease Control and Prevention
Anyang, Henan, China
Safety items of adverse reactions
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Time frame: within 7 days post each vaccination
Safety items of SAE
Occurrence of SAE of each subject(Arm 1A-7B)
Time frame: within 6 months post last vaccination
Safety items of Hematological examination
Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)
Time frame: day 4 post vaccination
Safety items of Urine test
Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)
Time frame: day 4 post vaccination
Safety items of Blood chemistry test
Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)
Time frame: day 4 post vaccination
Safety items of pressure value
Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)
Time frame: day 4 post vaccination
Safety items of heart rate
Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)
Time frame: day 4 post vaccination
Safety items of adverse reactions
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Time frame: within 30 days post each vaccination
immunogencity items of seropositivity rates by ELISA
Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
Time frame: day 30 post last vaccination
immunogencity items of GMC by ELISA
Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
Time frame: day 30 post last vaccination
immunogencity items of GMI by ELISA
Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
Time frame: day 30 post last vaccination
immunogencity items of GMT
Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A、7B)
Time frame: day 30 post last vaccination
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