Revaccination with Pneumococcal Conjugate Vaccine - Characterization of the Immune Response after Polysaccharide (REPLAY) To characterize the immune response by ELISA and OPA at approximately one month after vaccination to a single dose of PCV13 challenge in children vaccinated with a primary series (3 or 2 doses) of PCV...

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A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings To evaluate clinically significant FVIII inhibitor development in a large number of severe hemophila A patients treated with ReFacto AF in usual use settings.

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A 3-MONTH, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, MULTICENTER, SAFETY, TOLERABILITY, AND EFFICACY STUDY OF 3 DOSES OF SRA-333 IN OUTPATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE WITH DONEPEZIL AS ACTIVE CONTROL The primary objective is to determine the safety, tolerability, and efficacy of 3 doses of SRA-333 in patients with mild to moderate AD over 12 weeks.

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Postoperative Ileus After Ventral Hernia Repair The primary objective of this study is to assess the efficacy of IV MOA-728 in subjects who have undergone repair of large (³10 cm) ventral hernias, with or without a mesh prosthesis via laparotomy or...

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Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment To describe the effect on subjects in whom PSO has responded to initial treatment with ETN of 2 different strategies for managing a good response or complete response (PGA = 1or 0) over a 52-week time...

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A phase 3 randomized, placebo-controlled, double-blind study of oral CCI-779 administered in combination with letrozole vs. letrozole alone as first line hormonal therapy in postmenopausal women with locally advanced or metastatic breast cancer Assessment of overall progression free survival (PFS)

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A Randomized Double-Blind Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25 mg Twice Weekly in Subjects with Moderate to Severe Persistent Asthma To assess the efficacy and safety of etanercept 25 mg twice weekly in subjects with moderate to severe persistent asthma

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A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months after the administration of the toddler dose in study 6096A1-008-EU, as measured by serotype-specifi...

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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE Primary: To evaluate the safety and tolerability of long-term therapy with three dose levels (2, 5, 10 mg daily) of Lecozotan (SRA-333) SR administered to patients with mild to moderate Alzheimer’s ...

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A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD

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