NCT01048190

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 60 Days – 90 Days
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2010-01-13
• Last updated: 2010-01-14

Locations

1 site across 1 country: China