Poliomyelitis Clinical Trial
Official title:
The Phase Ⅱ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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