Clinical Trial Results:
Estudio de vacunación, fase III, observador ciego, aleatorizado (3:3:2), control activo, multinacional, multicéntrico para evaluar la respuesta inmune celular y humoral de la vacuna FLU NG de GSK Biologicals [GSK2186877A] comparada con Fluarix™ en adultos de 65 años y mayores, y comparada con Fluarix™ en adultos jóvenes de 18 a 40 años.
A phase III, observer-blind, randomized (3:3:2), active-controlled, multi-country, multi-center study to evaluate the cell mediated and humoral immune responses to GSK Biologicals’ FLU NG vaccine [GSK2186877A] compared to Fluarix™ in adults 65 years of age and older, and compared to Fluarix™ in younger 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 |
2008-004711-35 |
Trial protocol |
ES |
Global completion date |
04 Dec 2009
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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 |
22 Sep 2016
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First version publication date |
22 Sep 2016
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Other versions |
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Summary report(s) |
112147-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.