NCT00197249

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,034 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-06-01
• Completion: 2005-11-01
• First posted: 2005-09-20
• Last updated: 2016-09-09