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A phase III long-term follow-up study to assess antibody persistence and immunological memory in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-005392-34

A phase III long-term follow-up study to assess antibody persistence and immunological memory in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study 10PN-PD-DIT-001 and booster vaccination study 10PN-PD-DIT-007 and assessment of immune responses following a 2-dose catch-up immunization with GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal vaccine in the 6th year of life

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Extrait

•To assess the antibody persistence 1 year post booster (12 to 14 months), 2 years post booster (24 to 26 months) and 4 years post booster (48 to 50 months) following a four dose vaccination course with a pneumococcal conjugate vaccines

Critère d'inclusion

  • Subjects who participated in booster study 10PN-PD-DiT-007 in Poland and who received the full vaccination course (i.e. four doses) with a pneumococcal vaccine, co-administered with DTPa-HBV-IPV/Hib, will be followed-up to evaluate the long-term persistence of antibodies at approximately 30, 42 and 66 months of age and will be vaccinated in the 6th year of life against Streptococcus pneumoniae in parallel with age-matched unprimed subjects

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