drugset / Trial / NCT01037114

Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult

NCT01037114

Phase 4 Completed 50 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelPrevention

Summary

This study will evaluate the persistence of the immune response to HAV (hepatitis A virus) antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with Twinrix Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A \& B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit. No new subjects will be recruited during this study.

Timeline

Start
2010-01-27
Primary completion
2014-02-28
Completion
2014-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Engerix-B Vaccine
Subject Havrix Vaccine