Clinical Trial: The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Brief Summary: The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Detailed Summary:

The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Sponsor: Chinese Academy of Medical Sciences

Current Primary Outcome: To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ]

Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: January 12, 2010
Date Started: August 2008
Date Completion:
Last Updated: January 13, 2010
Last Verified: August 2008