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A Phase 3, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy T...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-000145-39

A Phase 3, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Toddlers 12 Months of Age, Compared to Single Dose of Meningococcal C Conjugate Vaccine

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Extrait

Immunogenicity objectives 1.To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine given to healthy toddlers, as measured by the percentage of subjects with serum bactericidal assay using human complement (hSBA) titers ≥8 against N. meningitidis serogroup C, at 28 days after the vaccination. Safety objectives: 1. To assess the safety and reactogenicity of MenACWY and MenC vaccines.

Critère d'inclusion

  • To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine
  • given to healthy toddlers, as measured by the percentage of subjects with serum
  • bactericidal assay using human complement (hSBA) titers ≥8 against N.
  • meningitidis serogroup C, at 28 days after the vaccination

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