Clinical Trial Results:
A phase IV, open-label, non-randomised, multicentre study to assess the immunogenicity and reactogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus, acellular pertussis and inactivated poliovirus vaccine dTpa-IPV (Boostrix Polio) when administered in healthy adults, 10 years after a booster vaccination in study 711866/003 (dTpa-IPV-003).
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 |
2009-012219-16 |
Trial protocol |
DE |
Global completion date |
01 Mar 2012
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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 |
30 Oct 2016
|
First version publication date |
30 Oct 2016
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Other versions |
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Summary report(s) |
113060-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.