Clinical Trial Results:
A phase II, observer-blind, randomized study to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with GSK Biologicals’ A/California/7/2009 (H1N1)v-like vaccine containing the AS03 adjuvant when co-administered with GSK Biologicals’ seasonal 2009-2010 influenza vaccine Fluarix™ either at the time of first or second vaccination in elderly subjects aged 61 years and older.
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 |
2009-013931-39 |
Trial protocol |
SE |
Global completion date |
23 Sep 2010
|
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 |
04 Sep 2016
|
First version publication date |
04 Sep 2016
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Other versions |
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Summary report(s) |
113525-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.