Clinical Trial Results:
Ensayo clínico abierto en fase IV, para evaluar la inmunogenicidad y reactogenicidad de la vacuna combinada DTPa (Infanrix) de GlaxoSmithKline Biologicals administrada como dosis de recuerdo a los 4 años de edad en niños prematuros (<37 semanas) en comparación con niños nacidos a término, que previamente recibieron 4 dosis de la vacuna DTPa-HBV-IPV/Hib (Infanrix hexa) a los 2, 4, 6 y 18 meses de edad.
Summary
|
|
EudraCT number |
2004-001223-37 |
Trial protocol |
ES |
Global completion date |
22 Feb 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 |
23 Oct 2019
|
First version publication date |
23 Oct 2019
|
Other versions |
|
Summary report(s) |
102038 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.