Clinical Trial Results:
A phase III, observer-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological equivalence of the Quebec-manufactured A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A as compared to the Dresden-manufactured A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A.
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 |
2009-014419-11 |
Trial protocol |
FR DE |
Global completion date |
04 Nov 2010
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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 |
03 Sep 2016
|
First version publication date |
03 Sep 2016
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Other versions |
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Summary report(s) |
113535-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.