Clinical Trial Results:
An open, randomized phase I/II study to demonstrate the non inferiority in term of cellular mediated immune response between GlaxoSmithKline Biologicals influenza candidate vaccines containing various adjuvants administered in elderly population (aged 65 years and older) and Fluarix™ (known as alpha-Rix™ in Belgium) administered in adults (18-40 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 |
2005-002360-28 |
Trial protocol |
BE |
Global completion date |
14 May 2006
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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 |
26 Sep 2016
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First version publication date |
26 Sep 2016
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Other versions |
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Summary report(s) |
104886-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.