Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Wilrijk, Belgium

About this study

All subjects who participated in the primary vaccination study, where subjects who received GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study.
Written informed consent obtained from the subject for the long-term follow-up.

Treatment and study plan

Hepatitis B vaccine

Biological

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate the Anti-HBs Antibody Persistence, in Subjects Who Received GSK Biologicals' Preservative-free or Thiomersal-free Engerix™-B or Engerix™-B Containing Thiomersal, Approximately 5 to 6 Yrs Earlier

Important dates

Study start: 2006
Study completion: 2006
First posted: May 24, 2006
Registry last updated: Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed