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A phase IIIa single-blind, controlled multicentre study to assess the safety, reactogenicity and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine or Prevenar when given as a ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001628-38

A phase IIIa single-blind, controlled multicentre study to assess the safety, reactogenicity and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine or Prevenar when given as a fourth dose between 12-18 months of age in children previously vaccinated in infancy in the primary study 10PN-PD-DIT-001 (105553) with either GSK Biologicals 10-valent pneumococcal conjugate vaccine or Prevenar

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Extrait

• To demonstrate that a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV/Hib vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C. Criteria for safety: Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (10Pn-10Pn group minus 7Pn-7Pn group), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%.

Critère d'inclusion

  • Booster vaccination against Streptococcus pneumoniae in children 12 to 18 months old

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