Clinical Trial Results:
A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults (≥66 years) previously vaccinated in the FluAS25-004 clinical trial with the same candidate vaccine. Fluarix™ (known as α-Rix in Belgium) administered in young (19-42 years) and elderly (≥66 years) adults 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
|
|
EudraCT number |
2007-002880-29 |
Trial protocol |
BE |
Global completion date |
28 Nov 2007
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
12 Oct 2016
|
First version publication date |
12 Oct 2016
|
Other versions |
|
Summary report(s) |
110263-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.