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A Phase 3b, Randomized, Open-label, Multi-Center Study Assessing Immunogenicity, Safety and 1 Year Persistence of Antibodies after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, ad...

Mise à jour : Il y a 5 ans
Référence : EUCTR2011-004421-27

A Phase 3b, Randomized, Open-label, Multi-Center Study Assessing Immunogenicity, Safety and 1 Year Persistence of Antibodies after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Children 2 to 10 years of age. Több vizsgálóhelyre tervezett klinikai vizsgálat az immunogenitás, a biztonságosság értékelésére egy vagy két adag agyhártyagyulladás elleni Novartis (Meningococcus ACWY) oltóanyag, 2-10 éves egészséges gyermekeknél történő alkalmazása után

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Extrait

Immunogenicity objectives: Primary 1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 2 to 5 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination. 2. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 6 to 10 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination. Safety objectives: •All adverse events (AEs) reported during days 1 to 7 after each vaccination; •All medically attended AEs reported from study day 1 to study termination/early termination; •All Serious adverse events (SAEs) reported from study day 1 to study

Critère d'inclusion

  • Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to healthy children 2 to 10 years of age

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