Clinical Trial Results:
A phase I/II, randomized, observer blinded study to evaluate and compare the safety, reactogenicity and immunogenicity of various formulations of the GlaxoSmithKline Biologicals’ adjuvanted 11-valent pneumococcal conjugate vaccine versus the licensed single-dose 23-valent pneumococcal polysaccharide vaccine and GlaxoSmithKline Biologicals’ aluminium-based 10-valent pneumococcal conjugate vaccine, in healthy elderly subjects.
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 |
2005-005682-11 |
Trial protocol |
SE BE FI |
Global completion date |
19 Jun 2007
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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 |
13 Oct 2016
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First version publication date |
13 Oct 2016
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Other versions |
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Summary report(s) |
106068-Clinical-Study-Results-Summary 106072-Clinical-Study-Results-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.