Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-003514-91

Femme et Homme

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Extrait

To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine with the immunogenicity of a single injection of PS vaccine (Menomune), defined as the percentage of subjects with seroresponse in human serum bactericidal assay against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age. To compare the percentage of subjects presenting at least one severe (solicited) systemic reaction to the Novartis MenACWY conjugate vaccine with the percentage presenting at least one severe systemic reaction to the licensed meningococcal ACWY polysaccharide (PS) vaccine (Menomune) during the first 7 days (day 1 to 7) following a single injection administered to healthy children 2 to 10 years of age.


Critère d'inclusion

  • Novartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis A, C, W-135 and Y