A Phase IIIb clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 to 5 years. The objective of the study is to evaluate the the Lot-to-Lot consistency, immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind phase IIIb clinical trial.
A phase IIIb 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 children aged approximately 2 to 5 years. The trial is a randomized, double-blind study. The objective of this study is to evaluate theLot-to-Lot consistency, immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. A total of at least 1125 participants will be enrolled. Participants wiil be randomized in a 1:1:1 ratio into three groups to receive different lots of commercially manufactured PCV13.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,125
One dose of Sinovac PCV13 lot 1 (0.5ml) was administered
One dose of Sinovac PCV13 lot 2 (0.5ml) was administered
One dose of Sinovac PCV13 lot 3(0.5ml) was administered
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention (Xinjiang Uygur Autonomous Region Academy of Preventive Medicine, Xinjiang Uygur Autonomous Region Public Health Inspection and Testing Center)
Ürümqi, Xinjiang, China
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination
Equivalence Criterion: The 95% confidence intervals (CIs) for the ratios of serotype-specific IgG geometric mean concentrations (GMCs) between any two lots shall lie entirely within the range of 0.5 to 2.0,as measured by enzyme-linked immunosorbent assay (ELISA) method
Time frame: 30 days after vaccination
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after vaccination
Percentage of IgG antibody concentration ≥0.35 μg/ml at 30 days after vaccination, as measured by ELISA method
Time frame: 30 days after vaccination
Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml 30 days after vaccination
Percentage of IgG antibody concentration ≥1.0 μg/ml at 30 days after vaccination, as measured by ELISA method
Time frame: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) from pre-vaccination up to 30 days post-vaccination
IgG GMI for the pneumococcal serotypes were measured by ELISA method
Time frame: Pre-vaccination up to 30 days post-vaccination
Incidence of adverse reactions within 7 days after vaccination
Incidence of adverse reactions within 7 days after vaccination.Adverse reactions consisted of solicited and unsolicited events. Solicited local (injection-site) symptoms included Pain, swelling, erythema, induration, pruritus, solicited systemic (non-injection-site) symptoms included Fever (axillary temperature), decreased appetite, diarrhoea, vomiting, nausea, cough, lethargy, headache, hypersensitivity reaction
Time frame: 0-7 days after vaccination
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Incidence of adverse reactions within 30 days after vaccination
Incidence of adverse reactions within 30 days after vaccination.Adverse reactions consisted of solicited and unsolicited events. Solicited local (injection-site) symptoms included Pain, swelling, erythema, induration, pruritus, solicited systemic (non-injection-site) symptoms included Fever (axillary temperature), decreased appetite, diarrhoea, vomiting, nausea, cough, lethargy, headache, hypersensitivity reaction
Time frame: 0-30 days after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Incidence of serious adverse reactions within 6 months after vaccination
Time frame: 0-6 months after vaccination