Clinical Trial Results:
A multi-centre, open-label, clinical, phase 4 trial, following on from a head-to-head comparison study of two H1N1 influenza vaccines in children, to compare firstly, the persistence of antibody against the A/California/7/2009 (H1N1) virus and secondly the immunogenicity and reactogenicity of one dose of a non-adjuvanted trivalent seasonal influenza vaccine, in children who had received a two-dose immunisation regimen of Celvapan or Pandemrix.
Summary
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EudraCT number |
2010-022817-24 |
Trial protocol |
GB |
Global completion date |
05 Aug 2011
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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 Nov 2018
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First version publication date |
02 Nov 2018
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Other versions |
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Summary report(s) |
A 1-year follow-on study from a randomised, head-to-head, multicentre, open-label study of two pandemic influenza vaccines in children |
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.