The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Laishui Center for Disease Control and Prevention
Laishui, Hebei, China
RECRUITINGAdverse events in 30 minutes
Occurrence of adverse events in 30 minutes after each vaccination
Time frame: 30 minutes after each vaccination
Solicited adverse events during 7 days
Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination
Time frame: 7 days after each vaccination
Unsolicited adverse events during 30 days
Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination
Time frame: 30 days after each vaccination
SAE
Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations
Time frame: from enrolling to 6 months after all vaccinations
Blood routine of subjects over 18 years old at the fourth day
Blood routine test results of subjects over 18 years old at the fourth day after vaccination
Time frame: 4 days after vaccination
Blood biochemistry of subjects over 18 years old at the fourth day
Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination
Time frame: 4 days after vaccination
Urine routine of subjects over 18 years old at the fourth day
Urine routine test results of subjects over 18 years old at the fourth day after vaccination
Time frame: 4 days after vaccination
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Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects
Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine
Time frame: 30 days after immunization
GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects
Geometric mean concentration (GMC) of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine
Time frame: 30 days after immunization