Clinical Trial Results:
A phase I/II, open, controlled study in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals influenza candidate vaccine containing the adjuvant AS25 (FluAS25) in an elderly population aged over 65 years (>65 years-old) previously vaccinated in 2004 with the same candidate vaccine in FLUAS25-001 clinical trial. For immunogenicity and safety evaluations, Fluarix™ (known as alpha-Rix™ in Belgium)vaccine will be used as reference.
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 |
2005-001928-37 |
Trial protocol |
BE |
Global completion date |
04 Nov 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? |
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 |
24 Sep 2016
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First version publication date |
24 Sep 2016
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Other versions |
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Summary report(s) |
104540-Clilnical-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.