Clinical Trial Results:
A phase II, observer-blind, multicountry, multicentre, randomized study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ influenza vaccine adjuvanted with various doses of the oil in water emulsion and MPL, administered in adults aged 65 years and older, and compared to Fluarix™.
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 |
2007-003802-86 |
Trial protocol |
DE SE NL GB |
Global completion date |
10 Jun 2008
|
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 |
14 Oct 2016
|
First version publication date |
14 Oct 2016
|
Other versions |
|
Summary report(s) |
110847-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.