A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.
A phase Ⅲ clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,080
One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
One dose of Prevnar® (0.5 mL) is administered intramuscularly.
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China
RECRUITINGProportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Time frame: 30 days after primary vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC
Time frame: 30 days after booster vaccination
Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8
Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Time frame: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Time frame: 30 days after primary vaccination
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Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Pneumococcal serotype-specific IgG GMI
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Pneumococcal serotype-specific OPA antibody GMI
Time frame: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Pneumococcal serotype-specific IgG GMI
Time frame: 30 days after booster vaccination
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)
Pneumococcal serotype-specific OPA antibody GMT
Time frame: 30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)
Pneumococcal serotype-specific OPA antibody GMI
Time frame: 30 days after booster vaccination
Safety of Sinovac PCV13
Incidence of adverse reactions
Time frame: 0-30 days within each dose
Safety of Sinovac PCV13
Incidence of serious adverse events
Time frame: 6 months within final dose