Clinical Trial Results:
A Phase I-II partially-blinded, randomized, dose- ranging study (10-30-90 mcg) to compare the safety and immunogenicity of GSK Biologicals’ candidate HIV vaccine F4co (p24-RT-Nef-p17), adjuvanted or not with AS01B, administered intramuscularly according to a vaccination schedule of 0, 1 month to healthy adult HIV seronegative volunteers, aged 18 to 40 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 |
2006-003796-12 |
Trial protocol |
BE |
Global completion date |
13 Jun 2008
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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 |
19 Nov 2016
|
First version publication date |
19 Nov 2016
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Other versions |
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Summary report(s) |
113165-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.