Clinical Trial Results:
A phase II, controlled, randomized, multicentre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of the AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-64 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
|
|
EudraCT number |
2007-003776-18 |
Trial protocol |
DE ES FR |
Global completion date |
08 May 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 |
16 Oct 2016
|
First version publication date |
16 Oct 2016
|
Other versions |
|
Summary report(s) |
110794-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.