- ICH GCP
- Registro delle prove cliniche dell'UE
Prove cliniche Nct
Clinical Trial Results:
A phase III, partially blind, randomised, primary vaccination study to assess the immunogenicity and safety of three different lots of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine (MeMuRu-OKA), when given as a two-dose schedule to healthy children in their second year of life.
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 | 2004-005123-18 |
Trial protocol | FI DE |
Global completion date | 21 Nov 2005 |
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? | Yes |
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 | 04 Jan 2017 |
First version publication date | 04 Jan 2017 |
Other versions | |
Summary report(s) | 104020-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.