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A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-004455-29

A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with the Hepatitis B surface antigen (HBsAg), according to a 0, 1 month schedule with a booster at Month 12, in healthy, Hepatitis B virus (HBV) naïve, adults

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Extrait

To compare the magnitude of the cellular immune response, post dose 2 at Day 44, induced by various GSK Adjuvant Systems in combination with the HBsAg, in adult subjects aged between 18 and 45 years old, inclusive, in good general health and not previously immunized or previously infected with Hepatitis B.

Critère d'inclusion

  • Hepatitis B surface antigen (HBsAg) vaccine administred in HBV naïve adult subjects aged between 18 and 45 years old, inclusive, in good general health

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