Clinical Trial Results:
A phase III open (partially double-blind), controlled, multicenter, multicountry primary & booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C response of GlaxoSmithKline Biologicals’ Hib-MenC vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and immunogenicity of Hib-MenC when given as a booster dose at 12-15 months of age.
Summary
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EudraCT number |
2004-003769-33 |
Trial protocol |
GB |
Global completion date |
13 Jul 2006
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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? |
Yes
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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 |
16 May 2019
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First version publication date |
16 May 2019
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Other versions |
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Summary report(s) |
103974/104056- CSR synopsis |
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.