A Phase 1 interventional study of Inactivated Poliomyelitis Vaccine (Sabin strains) and Inactivated Poliomyelitis Vaccine (Sabin strains) in Poliomyelitis, sponsored by Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 60 Days to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-14.
Sponsored by Chinese Academy of Medical Sciences · Phase 1, Interventional, and Prevention
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.
222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.
This study's enrollment of 130 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Also known as: Sabin IPV,lot No.20080303
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Also known as: Sabin IPV, lot No.20080302
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Also known as: Sabin IPV, lot No.20080301
To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time frame: one year
To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time frame: one year
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences