The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)

Phase 3 Completed 1200 enrolled Institute of Medical Biology, Chinese Academy of Medical Sciences Guangxi Center for Disease Control and Prevention · collab National Institute for the Control of Pharmaceutical and Biological Products, China · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).

Timeline

Start: 2012-01
Primary completion: 2015-09
Completion: 2015-09

Publications

Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inactivated Poliomyelitis Vaccine (Salk strains)	Vaccine	0.5 ml	Intramuscular
Subject	Sabin-IPV	Vaccine	0.5 ml	Intramuscular

The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)

Summary

Timeline

Publications

Drugs

Indications