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A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis M...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003476-35

A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

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Extrait

To assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month course of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age To evaluate the safety and tolerability of Novartis MenACWY vaccine when given at 2 and 4 months of age concomitantly with a combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine (DTaP-Hib-IPV, Pediacel®) and a heptavalent PCV (Prevenar®) To evaluate the safety and tolerability of Novartis MenACWY vaccine when given with or without concomitant PCV at 12 months of age

Critère d'inclusion

  • The Novartis Meningococcal A, C, W-135 and Y Vaccine is intended for prevention of meningitidis and/or septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y

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