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A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), thr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-008104-41

A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage

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Extrait

•To demonstrate the immunological memory induced following primary vaccination in study 10PN-PD-DIT-010 (107017) and booster vaccination in study 10PN-PD-DIT-014 (107137) with the 10Pn-PD-DiT vaccine, through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, compared to the unprimed group. Criteria for immune memory: The immune memory will be demonstrated if the lower limit of the 95% CI around the GMC ratios (pooled primed groups over unprimed group) is higher than 1 for all 10 vaccine serotypes.

Critère d'inclusion

  • Subjects aged 31-44 months previously vaccinated with GSK Biologicals’ 10Pn-PD-DiT vaccine and age-matched unprimed children who participated in study 10PN-PD-DIT-014 (107137)

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