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Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, ...

Mise à jour : Il y a 5 ans
Référence : EUCTR2013-002454-78

Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B. Estudio realizado en pacientes inmunodeprimidos de 2 a 17 años de edad, que presentan un riesgo alto de adquirir enfermedades meningocócicas graves debido a asplenai of deficiencia en el sistema de complemento, en comparación con controles sanos para evaluar la seguridad, tolerabilidad y respuesta inmune tras la administración de dos dosis de la vacuna de investigación de Novartis frente a Meningococo del serogrupo B

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Extrait

Immunogenicity Objective ? To evaluate the immunogenicity of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects, at 1 month after the second vaccination. Safety Objective ? To assess the safety and tolerability of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects. Evaluar la inmunogenicidad de dos dosis de rMenB+OMV NZ en sujetos con riesgo elevado de padecer una enfermedad meningocócica a causa de una deficiencia de complemento o asplenia y en sujetos sanos agrupados por edad, un mes después de la segunda vacunación Evaluar seguridad

Critère d'inclusion

  • Meningococcal Group B disease

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