Clinical Trial Results:
A phase II, open-label, randomised study to assess the safety and immunogenicity of a birth dose of GSK Biologicals’ reduced-antigen-content tri-component pertussis vaccine followed by routine paediatric vaccination at 2, 4, 6 and 12-18 months of age, and to explore the ability of this schedule to accelerate the acquisition of pertussis antibodies.
Summary
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EudraCT number |
2009-012460-14 |
Trial protocol |
NL GB BE |
Global completion date |
26 Aug 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 Jan 2019
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First version publication date |
30 Jan 2019
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Other versions |
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Summary report(s) |
Cancelled before Active Statement |
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.