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

NCT01037114 PHASE4 COMPLETED Results posted

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.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE4
Status	COMPLETED
Enrolment	50
Start date	Wed Jan 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Feb 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Hepatitis A
• Hepatitis B

Interventions

• Blood sampling
• Engerix-B
• Havrix

Countries

Belgium