Clinical Trial Results:
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.
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
Summary
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EudraCT number |
2008-004455-29 |
Trial protocol |
BE DE |
Global completion date |
14 Jul 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Aug 2016
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First version publication date |
27 Aug 2016
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Other versions |
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Summary report(s) |
112115-Clinical-Study-Result-Summary |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.