Clinical Trial: The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Phase Ⅱ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Brief 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).
Detailed Summary:
The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by microcarrier 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.
Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.
This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.
Sponsor: Chinese Academy of Medical Sciences
Current Primary Outcome: To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants . [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Chinese Academy of Medical Sciences
Dates:
Date Received: January 25, 2010
Date Started: July 2009
Date Completion:
Last Updated: July 31, 2016
Last Verified: July 2016
