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A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-004754-82

A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers

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Extrait

The primary objective of this phase 3 study is to demonstrate the safety and immune response of MenACWY compared to Menjugate when administered to healthy toddlers at 12 months of age. Subjects will receive Infanrix-hexa and Prevenar at 12 months of age

Critère d'inclusion

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

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