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NCT ID: NCT01934140 Completed - Clinical trials for Infections, Meningococcal

Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated. All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.

NCT ID: NCT01930890 Terminated - Lupus Nephritis Clinical Trials

BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

NCT ID: NCT01930357 Completed - Rabies Clinical Trials

Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years. Primary Objectives: - To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination. - To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group. Secondary Objectives: - To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule. - To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination - To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.

NCT ID: NCT01926353 Completed - Clinical trials for Urinary Tract Infection

Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux

Start date: July 2013
Phase: N/A
Study type: Observational

Endoscopic correction of VUR has gained its popularity due to its less invasiveness, associated low morbidity and short hospital stay. Although short term follow-up had justified their efficacy; however, long term recurrence and complications following endoscopic correction were also being reported in the literatures (6). Currently, there are insufficient evidences on the efficacy and safety of biocompatible tissue augmenting materials used for endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue augmenting biocompatible Acrylics used for endoscopic correction of VUR.

NCT ID: NCT01922102 Completed - Clinical trials for Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)

Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Brilliance
Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (PM)

NCT ID: NCT01920711 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

PARAGON-HF
Start date: July 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

NCT ID: NCT01917357 Completed - Hepatitis B Clinical Trials

A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

NCT ID: NCT01914757 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

NCT ID: NCT01914393 Completed - Schizophrenia Clinical Trials

Pediatric Open-Label Extension Study

Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

NCT ID: NCT01911429 Completed - Schizophrenia Clinical Trials

Pediatric Schizophrenia Efficacy and Safety Study

Start date: August 2013
Phase: Phase 3
Study type: Interventional

Efficacy and Safety study of Lurasidone in pediatric patients.