drugset / Trial / NCT01056705
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)
Phase 2
Completed
500 enrolled
Chinese Academy of Medical Sciences
Guangxi Center for Disease Control and Prevention · collabNational Institute for the Control of Pharmaceutical and Biological Products, China · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Timeline
- Start
- 2009-07
- Primary completion
- 2010-05
- Completion
- 2010-08
Publications
- Sun M, Li C, Xu W, Liao G, Li R, Zhou J, Li Y, Cai W, Yan D, Che Y, Ying Z, Wang J, Yang H, Ma Y, Ma L, Ji G, Shi L, Jiang S, Li Q. Immune Serum From Sabin Inactivated Poliovirus Vaccine Immunization Neutralizes Multiple Individual Wild and Vaccine-Derived Polioviruses. Clin Infect Dis. 2017 May 15;64(10):1317-1325. doi: 10.1093/cid/cix110.
- Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inactivated Poliomyelitis Vaccine (Sabin strains) | Vaccine | 0.5 ml | Intramuscular |
| Subject | Inactivated Poliomyelitis Vaccine (Salk strains) | Vaccine | 0.5 ml | Intramuscular |
| Subject | Oral Poliomyelitis Vaccine | Vaccine | 0.5 ml | Oral |