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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 ...

Update Il y a 4 ans
Reference: 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

Woman and Man

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Extract

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.

Inclusion criteria

  • 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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