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Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity

Hepatitis A Clinical Trial

Official title:
A Phase III, Open, Randomized, Multicentric Study to Compare the Reactogenicity and Immunogenicity of GSK Biologicals' Combined Vi Polysaccharide Typhoid Vaccine and Inactivated Hepatitis A Vaccine, to That Elicited by GSK Biologicals' Hepatitis A Vaccine, Administered Singly or Concomitantly With GSK Biologicals' Vi Polysaccharide Vaccine

Clinical Trial Summary

To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine.

Clinical Trial Description

Compare the reactogenicity & immunogenicity of GSK Biologicals' combined Vi polysaccharide typhoid vaccine & inactivated hepatitis A vaccine, Hepatyrix, to that elicited by GSK Biologicals' hepatitis A vaccine, Havrix administered singly or concomitantly with GSK Biologicals' Vi polysaccharide vaccine, Typherix, & to that elicited by Aventis Pasteur's monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy subjects aged 18-65 yrs. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00197249
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date May 2002
Completion date November 2005
View Details
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