This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine
This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial in subjects aged 2 months (minimum 6 weeks) and above. The experimental vaccine was manufactured by Sinovac Research \& Development Co., Ltd. .And one of the positive control vaccine was manufactured by WALVAX Biotechnology Co., Ltd( WALVAX PCV13) ,the other manufactured by Pfizer(Pfizer PCV13).A total of 310 subjects including 20 adults aged 18-49 years,20 adolescents and children aged 6\~7 years ,60 children aged 2-5 years,60 infants aged 12\~23 months,60 infants aged 7 \~11 months,60 infants aged 2 months (minimum 6 weeks), and 30 infants aged 3 months will be enrolled.Subjects will be assigned to receive one dose , two doses ,three doses or four doses of experimental vaccine or different positive control vaccines . Subjects aged 18-49 years will receive one dose of experimental vaccine.Subjects aged 6\~17 years will receive one dose of experimental vaccine.Subjects aged 2\~5 years will be randomly divided into two groups in a ratio of 1:1,and each group will receive one dose of experimental vaccine or control vaccine(WALVAX PCV13).Subjects aged 7 \~ 11 months and subjects aged 12 \~23 months will be randomly divided into two groups in a 1:1 ratio,the subjects aged 12 \~ 23 months will receive two doses of experimental vaccine or control vaccine on the schedule of month 0,2 .Subjects aged 7 \~11 months will receive 3 doses of experimental vaccine or control vaccine (WALVAX PCV13)on the immunization schedule of month 0,2,4.Subjects aged 3 months will receive 4 doses of experimental vaccine.Subjects aged 2 months will be randomly divided into 2 groups in a 1:1 ratio and each group will receive 4 doses of experimental vaccine or control vaccine (Pfizer PCV13).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
310
The investigational vaccine was manufactured by Sinovac Research \& Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
Time frame: Day 0-30 after each dose of experimental vaccine
Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
Time frame: Day 0-7 after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
Time frame: Day 3 after vaccination after each dose of experimental vaccine
Safety index-Incidence of serious adverse events during the safety observation period
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
Time frame: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
Time frame: Day 30 after vaccination
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
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The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.
Time frame: Day 30 after vaccination
Immunogenicity index-Seropositive rates,GMCs and GMI of serum specific antibody
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
Time frame: Day 30 after vaccination
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
Time frame: Day 30 after vaccination
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 \~ 11 months at 30 days before and after booster immunization
Time frame: Day 30 before and after booster immunization
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7\~ 11 months at 30 days before and after booster immunization
Time frame: Day 30 before and after booster immunization