NCT00603252

Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 41 Years
• Healthy volunteers: Accepted

Summary

This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).

Detailed description

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

Conditions

• Hepatitis B
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Twinrix
BIOLOGICAL	Engerix-B
BIOLOGICAL	Havrix
BIOLOGICAL	HBVAXPRO
BIOLOGICAL	Vaqta

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-01-29
• Last updated: 2017-03-14

Locations

8 sites across 2 countries: Belgium, Germany