A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days).
The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.
Health infants aged approximately 2 months (42 to 89 days)
Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
Be able to provide the vaccination records since birth.
The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old.
History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
Parallel
Sinovac PCV13
Biological/VaccineOne dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
Prevenar 13™
Biological/VaccineOne dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 2.
Geometric mean concentrations (GMCs) of serotype-specific IgG antibody.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 2.
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 3.
Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 3.
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL .
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3.
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