Clinical Trial Results:
A phase IIIb, randomized, open study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) when co-administered with GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) in healthy female subjects aged 20 to 25 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 |
2007-007876-41 |
Trial protocol |
BE |
Global completion date |
18 Jun 2009
|
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 |
27 Aug 2016
|
First version publication date |
27 Aug 2016
|
Other versions |
|
Summary report(s) |
111567-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.