Pneumonia AND sponsor name.
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Print Download Summary. Review by the Competent Authority or Ethics Committee in the country concerned. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:.
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IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters.
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Title of the trial for lay people, in easily understood, i. 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.
Studio in pazienti immunocompromessi da 2 a 17 anni, che sono a rischio di contrarre la malattia da meningocococco B, in quanto soggetti privi della milza o che presentano difetti nel complemento. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy.
Meningococcal Group B disease. In order to participate in this study, all subjects must meet ALL of the inclusion criteria applicable to the relevant group.
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Subjects aged 2 to 17 years inclusive at enrollment; 2. Inclusion criterion applicable to Group A 5. Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies: a. Secondary deficiencies: patients with a condition indirectly leading to a reduced concentration of one or more proteins in the complement cascade, including patients who are already in treatment with eculizumab at the time of enrollment and have been diagnosed with paroxysmal nocturnal hemoglobinuria or with atypical hemolytic uremic syndrome For patients with a secondary complement deficiency the investigator should include in the source documentation evidence of the increased risk of meningococcal disease based on reduced complement protein concentrations or on previous meningococcal infection.
This should be documented in the medical records. Inclusion criterion applicable to Group B 6. Subjects at risk of meningococcal disease because of functional or anatomic asplenia: a. Congenital anomalies of the spleen, isolated or in association with other splenic anomalies b. Surgical splenectomy, which may occur after significant splenic trauma or other clinical disorders, such as idiopathic autoimmune thrombocytopenic purpura c.
Autosplenectomy i. Le briciole del pranzo di Peter sono rimaste nelle pieghe della sua camicia.
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