Clinical Trial Results:
A phase IV, single-blinded, randomized, single centre study to demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, Engerix-B in multidose presentation to that elicited by Engerix-B in monodose presentation when administered according to 0, 1, 6 months schedule in healthy adults aged equal to or above 18 years.
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 |
2004-005262-20 |
Trial protocol |
BE |
Global completion date |
14 Dec 2005
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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? |
Yes
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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 |
25 Aug 2016
|
First version publication date |
25 Aug 2016
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Other versions |
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Summary report(s) |
104387 – 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.