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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.
Enrollment
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Volunteers
Inclusion criteria
All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
All subjects must satisfy the following criteria at entry into the challenge dose phase:
Exclusion criteria
The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:
The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase:
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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