An open multicentre, multicountry study to evaluate long-term antibody persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vaccinate...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-006083-11

An open multicentre, multicountry study to evaluate long-term antibody persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vaccinated with Twinrix™ Adult following a two-dose schedule or Twinrix™ Junior following a three-dose schedule

Femme et Homme

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Extrait

For the long-term follow-up phase: To evaluate anti-HAV and anti-HBs antibody persistence at Years 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose Twinrix Adult or a three-dose Twinrix Junior primary vaccination course. For the Challenge dose phase: To evaluate the immune memory 15 years after primary vaccination with a two-dose Twinrix Adult versus a three-dose Twinrix Junior vaccination course in subjects who became seronegative for anti-HAV antibodies (less than 15 mIU/ml) or whose anti-HBs antibody concentrations decreased below 10 mIU/ml during the long-term follow-up period.


Critère d'inclusion

  • Adult subjects who received a primary vaccination course with Twinrix Adult following a two-dose schedule or Twinrix Junior following a three-dose schedule as adolescents (12-15 years) approximately 11 to 15 years ago