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A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) B...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001481-17

A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine

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Extrait

To determine the percentage reduction in febrile reactions (rectal temperature >=38.0°C or oral/axillary/tympanic >=37.5°C) when prophylactic antipyretic treatment is administered compared to no prophylactic antipyretic treatment, after booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine and routine DTPa-HBV-IPV/Hib (Infanrix hexa) vaccination in children at 12-15 months of age.

Critère d'inclusion

  • A single dose booster vaccination against Streptococcus pneumoniae of healthy children between 12-15 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate pneumococcal vaccine in the primary vaccination study 10PN-PD-DIT-010 and a first single dose vaccination against meningococcal disease due to serogroups A, C, W-135, or Y, of pneumococcal vaccine unprimed healthy children of 12-15 months of age

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