An open-label, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immunogenicity and safety study of a single dose hepatitis B (Engerix™-B Kinder...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-002821-41

An open-label, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immunogenicity and safety study of a single dose hepatitis B (Engerix™-B Kinder) vaccine challenge in adolescents aged 12-13 years, previously primed and boosted in the first two years of life with four doses of GSK Biologicals’ DTPa-HBV-IPV/Hib (Infanrix™ hexa) vaccine

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Extrait

To assess the anti-HBs antibody response, in terms of subjects with antibody concentrations >= 100 mIU/ml, to a single challenge dose of HBV vaccine (Engerix-B Kinder) in subjects 12–13 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life.


Critère d'inclusion

  • Hepatitis B

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