Clinical Trial Results:
A phase II, observer-blind, randomised, placebo-controlled, adjuvant-dose selection, multicenter prophylactic vaccination study to evaluate the immunogenicity and safety of GSK Biologicals’ herpes zoster vaccine, gE/AS01B, in comparison to gE combined with ½ dose AS01B adjuvant (gE/AS01E), to unadjuvanted gE (gE/Saline), and to Saline (placebo) when administered twice in subjects aged 50 years and older.
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 |
2008-005120-86 |
Trial protocol |
CZ |
Global completion date |
02 Jul 2010
|
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 |
17 Aug 2016
|
First version publication date |
17 Aug 2016
|
Other versions |
|
Summary report(s) |
112077-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.