Clinical Trial Results:
Observer-blinded, randomised, controlled, phase I/II study, to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccines M72/AS01B and M72/AS02A when administered intramuscularly according to a vaccination schedule of 0, 1 month, to healthy PPD-negative adults aged 18 to 50 years.
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 |
2005-004497-24 |
Trial protocol |
BE |
Global completion date |
01 Dec 2009
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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 |
24 Aug 2016
|
First version publication date |
24 Aug 2016
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Other versions |
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Summary report(s) |
106227-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.