Hepatitis B Clinical Trial
Official title:
Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System
This study aims to develop innovative immunological read-outs and new technologies in order
to further characterise the early immune response and its kinetics as well as the adaptive
immune responses to adjuvanted vaccines.
This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults
vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals'
Adjuvant System.
This study will be conducted in 2 steps with 2 study groups in each step. The entire study
period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is
from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D.
Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day
60 visit. Step 2 will be conducted in an open-label manner.
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