Clinical Trial Results:
A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 18 – 25 years and to demonstrate non-inferiority of the candidate HPV vaccine manufactured at 600L scale compared with a lower (80L) manufacturing scale.
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 |
2005-001667-58 |
Trial protocol |
LT DK |
Global completion date |
01 Mar 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 |
27 Aug 2016
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First version publication date |
27 Aug 2016
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Other versions |
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Summary report(s) |
104772-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.