A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent Pneumococcal Polysaccharide Vaccine (23vPS) in Ambulatory Elderly Individuals Aged 70 Years and Older Who Received 1 Dose of 23vPS at Least 5 Years Before Study Enrollment [1] To demonstrate that 13vPnC is as immunogenic as 23vPS for the 12 common serotypes contained in 13vPnC as measured by serotype-specific opsonophagocytic assay (OPA) titers 1 month after initial stu...

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A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus versus Cyclosporine when Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients Efficacy: to demonstrate superiority of the sirolimus regimen versus Cyclosporine by intent-to-treat (ITT) analysis of renal function at 52 weeks, measured by mean calculated glomerular filtration rat...

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A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA The primary objective of this study is to compare the safety and efficacy of 2 higher tigecycline dose regimens with that of the imipenem/cilastatin regimen in order to determine the dose(s) of tigecy...

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A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Preparation (FLrFVIII, Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A Safety: To determine the incidence rate of Factor VIII inhibitors in the study patient population Efficacy: To establish the bioequivalence of ReFacto AF with a full-length recombinant Factor VIII (Ad...

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A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine Primary Objective: - To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after last scheduled dose of 13vPnC in each age group.

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A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who Received 1 or More Doses of 23-valent Pneumococcal Polysaccharide Vaccine at Least 3 Years Before Study Enrollment To evaluate the acceptability of the safety profile of a single injection of 13vPnC administered at least 3 years after 1 or more nonstudy doses of 23vPS as measured by the incidence rates of local r...

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A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23-valent Pneumococcal Polysaccharide Vaccine To evaluate the immune response 1 month after 2 doses of 13vPnC given 6 months apart compared to 1 month after 1 dose of 13vPnC as measured by fold rise in serotype specific IgG geometric mean concent...

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A 6-MONTH, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, SAFETY, TOLERABILITY, AND EFFICACY STUDY OF 3 DOSES OF LECOZOTAN SRA-333 SR IN OUTPATIENTS WITH MILD TO MODERATE ALZHEIMER S DISEASE TREATED WITH A CHOLINESTERASE INHIBITOR The primary objective is to determine the safety, tolerability, and efficacy of three doses of lecozotan SR 2, 5, 10 mg in combination with a cholinesterase inhibitor in patients with mild to modera...

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A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.

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A Phase 1 / 2 Study of HKI-272 in combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer Part 1: The primary objectives of part 1 are to assess the safety and tolerability, and to define the MTD of HKI-272 in combination with paclitaxel in subjects with advanced solid tumors Part 2: The p...

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