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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group of One Dose | Experimental | 110 Participants (including 20 subjects aged 18~49 years, 20 subjects aged 6~17 years , 30 subjects aged2-5 years) will receive one dose of experimental vaccine |
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| Experimental Group of Two Doses | Experimental | 30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2. |
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| Experimental Group of Three Doses | Experimental | 30 Participants aged 7~11 months will receive two doses of experimental vaccine on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months . |
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| Experimental Group of Four Doses | Experimental | 30 Participants aged 3 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,1,2 and one dose of booster immunization during the participants aged 12~15 months ; 30 Participants aged 2 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of adverse reactions | Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine | Day 0-30 after each dose of experimental vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of adverse reactions | Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine | Day 0-7 after each dose of experimental vaccine |
| Safety index-incidence of abnormal indicators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang, Master | Henan Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Center for Diseases Control and Prevention | Zhengzhou | Henan | China |
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Open label design will be adopted for children and adolescents aged 6-17 years and infants aged 3 months, and randomized, blind and positive control design was adopted for other populations
| Control Group of One Dose With WALVAX PCV13 | Active Comparator | 30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13) |
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| Control Group of Two Doses With WALVAX PCV13 | Active Comparator | 30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2. |
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| Control Group of Three Doses With WALVAX PCV13 | Active Comparator | 30 Participants aged 7~11 months will receive two doses of control vaccine(WALVAX PCV13) on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months . |
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| Control Group of Three Doses With Pfizer PCV13 | Active Comparator | 30 Participants aged 2 months will receive three doses of control vaccine(Pfizer PCV13 on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months |
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| Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13) | Biological | 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. |
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| Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13) | Biological | 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. |
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Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
| 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) | 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 | 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 | 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 | 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 | 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 | 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 | Day 30 before and after booster immunization |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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