Clinical Trial Results:
A phase II, double-blind study to evaluate the safety, reactogenicity and immunogenicity of two different formulations of GSK Biologicals’ pneumococcal protein candidate vaccine, when given as a booster dose in healthy young adults previously vaccinated in the primary vaccination study SPNG-001 (111651).
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
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EudraCT number |
2009-011022-33 |
Trial protocol |
BE |
Global completion date |
05 Aug 2009
|
Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Aug 2016
|
First version publication date |
24 Aug 2016
|
Other versions |
|
Summary report(s) |
112993-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.