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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； * ...
It is an investigational vaccine developed by Sinovac Biotech, Ltd (ticker SVA) for the prevention of pneumococcal infections. It is designed to present 13 pneumococcal polysaccharide serotypes as conjugates. The vaccine is in Phase 1 clinical development and has been studied in a completed Phase 1 trial in China.
It is being developed for the prevention of pneumococcal infections. Pneumococcal disease is caused by Streptococcus pneumoniae bacteria. The vaccine is intended to stimulate immune protection against the serotypes included in its 13-valent formulation. It is investigational and has not been approved for use.
Sinovac Biotech, Ltd, which trades under the ticker SVA, is the developer of the Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine. The company conducted the Phase 1 study of the vaccine in China.
The Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine is in Phase 1 development. One Phase 1 trial has been completed. The vaccine is investigational and is not approved for any indication.
The vaccine has been evaluated in a completed Phase 1 trial, NCT05092386, titled Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine. The trial enrolled 310 healthy volunteers aged 6 weeks and older in China. It was randomized, double-blind, and active-controlled.