A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal ser...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-006460-32

A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine given at 12-15 months of age to subjects who were primed in primary study 103974 (HIB-MENC-TT-012) and boosted in study 104056 (HIB-MENC-TT-013 BST:012)

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Extrait

In all evaluable subjects of groups HibMenC and LicMenC at 12 months after the booster vaccination; in all evaluable subjects of groups HibMenC and LicMenC at 24 months after the booster vaccination; in all evaluable subjects of group NoBoost at 40-43 months of age; and in all evaluable subjects of groups HibMenC and LicMenC at 48 months after the booster vaccination: • To evaluate the persistence of meningococcal C antibodies • To evaluate the persistence of Haemophilus influenzae type b antibodies. In all UK evaluable subjects* of groups HibMenC and LicMenC: • To evaluate the persistence of anti-pertussis antibodies prior to Infanrix-IPV preschool booster and the response to Infanrix-IPV preschool booster 24 months later. * UK pediatric vaccination schedule recommends a DTP booster at the moment of Visit 2 (24 months after study booster vaccination) of our study; the Polish pediatric vaccination schedule recommends a DTP booster before Visit 1 of our study.


Critère d'inclusion

  • Persistence of antibodies after a 3-dose primary vaccination (in infancy) with or without a booster vaccination (in the second year of life) against Haemophilus influenzae type b disease and meningococcal disease due to serogroup C

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