Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine · 1 trial · 1 indication
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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. |
| 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 . |
| 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 |
| 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) |
| 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. |
| 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 . |
| 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Inclusion Criteria: * Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 \~ 11 months, healthy infants aged 12\~ 23 months, healthy children aged 2\~ 5 years, healthy adolescent and children aged 6\~ 17 years, healthy adults aged 18\~ 49 years； * ...