Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines

Vaccine

Volumn 31, Issue 14, 2013, Pages 1870-1876

  Tavares Da Silva, Fernanda ^a   De Keyser, Filip ^b   Lambert, Paul Henri ^c   Robinson, William H ^d   Westhovens, René ^e   Sindic, Christian ^f  

^a GSK   (Belgium)

^b GHENT UNIVERSITY   (Belgium)

^c UNIVERSITY OF GENEVA   (Switzerland)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF LEUVEN   (Belgium)

^f CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

Author keywords

Autoimmune disease; Clinical trial; Immune mediated; Safety; Vaccine

Indexed keywords

AUTOANTIBODY; SWINE INFLUENZA VACCINE; VACCINE;

ACUTE DISSEMINATED ENCEPHALOMYELITIS; ADDISON DISEASE; ADVERSE OUTCOME; ALOPECIA AREATA; ANAPHYLACTOID PURPURA; ANTIPHOSPHOLIPID SYNDROME; ANTISYNTHETASE SYNDROME; ARTICLE; AUTOIMMUNE HEPATITIS; AUTOIMMUNE THYROIDITIS; AUTOIMMUNITY; BELL PALSY; CELIAC DISEASE; CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY; CHURG STRAUSS SYNDROME; CLINICAL TRIAL (TOPIC); CONNECTIVE TISSUE DISEASE; CROHN DISEASE; DATA ANALYSIS; DATA BASE; DERMATOMYOSITIS; DIABETES MELLITUS; DIAGNOSTIC ACCURACY; DISEASE COURSE; DISEASE EXACERBATION; DRUG SAFETY; ENCEPHALITIS; ENCEPHALOMYELITIS; ERYTHEMA NODOSUM; FIBROSING ALVEOLITIS; GOODPASTURE SYNDROME; GUILLAIN BARRE SYNDROME; HISTOPATHOLOGY; HUMAN; IMMUNE MEDIATED DISORDER; IMMUNE RESPONSE; IMMUNOPATHOLOGY; INFORMATION PROCESSING; JUVENILE RHEUMATOID ARTHRITIS; LEUKOCYTOCLASTIC VASCULITIS; LICHEN PLANUS; MEDICAL DOCUMENTATION; METHODOLOGY; MONOCLONAL IMMUNOGLOBULINEMIA; MOTOR NEUROPATHY; MUCOCUTANEOUS LYMPH NODE SYNDROME; MULTIPLE SCLEROSIS; MYASTHENIA GRAVIS; MYELITIS; MYOCARDITIS; NARCOLEPSY; OPTIC NEURITIS; PARESIS; PERIPHERAL NEUROPATHY; PERNICIOUS ANEMIA; POLYCHONDRITIS; POLYMYOSITIS; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; PSORIASIS; PSORIATIC ARTHRITIS; QUESTIONNAIRE; RAYNAUD PHENOMENON; RELIABILITY; RHEUMATIC POLYMYALGIA; RHEUMATOID ARTHRITIS; SARCOIDOSIS; SIGNAL TRANSDUCTION; SKIN LUPUS ERYTHEMATOSUS; SWINE INFLUENZA; SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEMIC SCLEROSIS; THROMBOCYTOPENIA; ULCERATIVE COLITIS; VACCINATION; VITILIGO; WEGENER GRANULOMATOSIS;

ADJUVANTS, IMMUNOLOGIC; ADVERSE DRUG REACTION REPORTING SYSTEMS; AUTOIMMUNE DISEASES; CLINICAL TRIALS AS TOPIC; DATA COLLECTION; HUMANS; PRACTICE GUIDELINES AS TOPIC; VACCINATION; VACCINES;

EID: 84875246575     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.01.042     Document Type: Article

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