- ICH GCP
- Registro delle prove cliniche dell'UE
Prove cliniche Nct
Clinical Trial Results:
A double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old infants.
Summary | |
EudraCT number | 2004-002669-19 |
Trial protocol | IT |
Global completion date | 13 Sep 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 | 13 Apr 2016 |
First version publication date | 21 Jun 2015 |
Other versions | |
Summary report(s) | X04-VAR-402 CSR Synopsis |
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.