Clinical Trial Results:
A phase II, double-blind, randomized, placebo controlled study to compare the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ live attennuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV
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 |
2005-000449-12 |
Trial protocol |
FI |
Global completion date |
10 Nov 2005
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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? |
Yes
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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 |
25 Aug 2016
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First version publication date |
25 Aug 2016
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Other versions |
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Summary report(s) |
104480 – 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.