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A study comparing different formulations of Meningococcal C conjugate vaccine, one of which is a newly manufactured liquid formulation of the same vaccine. This study will be conducted in 12-23 months...

Mise à jour : Il y a 5 ans
Référence : EUCTR2011-000395-34

A study comparing different formulations of Meningococcal C conjugate vaccine, one of which is a newly manufactured liquid formulation of the same vaccine. This study will be conducted in 12-23 months old healthy children who will be randomly vaccinated with one of vaccine formulations in healthcare institutes

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Extrait

The equivalence of MenC-CRM liquid to Menjugate Kit and the equivalence of MenC-CRM ROS to Menjugate Kit will be simultaneously assessed with adjustment for multiple comparisons. 1. To demonstrate the equivalence of MenC-CRM liquid to Menjugate Kit when administered to toddlers, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N. meningitidis type C, approximately 28 days after a single vaccination. 2. To demonstrate the equivalence of MenC-CRM ROS to Menjugate Kit when administered to toddlers, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N. meningitidis type C, approximately 28 days after a single vaccination.

Critère d'inclusion

  • Prevention of meningococcal disease caused by serogroup C Neisseria meningitidis by evaluating the immunogenicity, tolerability, and safety of a liquid formulation of Novartis meningococcal C conjugate vaccine (MenC-CRM liquid) and of the lyophilized MenC-CRM vaccine produced with drug substance manufactured at Rosia, Italy, in comparison to the lyophilized MenC-CRM vaccine produced with drug substance manufactured at Emeryville, USA (Menjugate Kit)

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