Clinical Trial Results:
A phase III, observer-blind, multicountry, multicenter, study to evaluate the safety, reactogenicity and immunogenicity, of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine administered intramuscularly in adults aged 65 years and older previously vaccinated in the FluAS25-005 clinical trial with the same candidate vaccine. Fluarix™ administered in adults aged 65 years and older 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 |
2007-002368-83 |
Trial protocol |
DE BE |
Global completion date |
04 Jun 2008
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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 |
12 Oct 2016
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First version publication date |
12 Oct 2016
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Other versions |
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Summary report(s) |
109821-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.