Poliomyelitis Clinical Trial
Official title:
The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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