Clinical Trial Results:
A phase II open (partially double-blind), randomized, controlled, primary vaccination study to assess the immunogenicity, safety and reactogenicity of one intramuscular dose of four different formulations of GlaxoSmithKline (GSK) Biologicals’ new generations meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine versus one subcutaneous dose of MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 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 |
2005-000965-21 |
Trial protocol |
DK |
Global completion date |
27 Oct 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? |
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 |
02 Sep 2016
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First version publication date |
02 Sep 2016
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Other versions |
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Summary report(s) |
104702-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.