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Study ID Status Title Patient Level Data
580299/005 Completed A Phase II Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers Study Listed on ClinicalStudyDataRequest.com
580299/007 Completed Study of the efficacy of candidate HPV 16/18 VLP vaccine in the prevention of HPV-16 and/or HPV-18 cervical infection in adolescent & young adult women in North America and Brazil vaccinated in primary study 580299/001 Study Listed on ClinicalStudyDataRequest.com
580299/008 Completed A phase III, double-blind, randomized, controlled, multi-center study to evaluate the efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 vaccine compared to hepatitis A vaccine as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6 month schedule in healthy females 15-25 years of age. Study Listed on ClinicalStudyDataRequest.com
580299/009 Completed Study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica.
580299/011 Completed An observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years Study Listed on ClinicalStudyDataRequest.com
580299/012 Completed Immunogenicity: 3 consecutive lots of GSK Biologicals’ HPV-16/18 vaccine administered intramuscularly at 0,1,6 month schedule in healthy females aged 10–25 years and demonstrate non-inferiority of candidate HPV vaccine manufactured by modified production process Study Listed on ClinicalStudyDataRequest.com
580299/013 Completed Evaluate the safety and immunogenicity of GSK Biologicals’ HPV-16/18 vaccine administered intramuscularly according to a 0,1,6 month schedule in healthy female subjects (10 – 14 years) Study Listed on ClinicalStudyDataRequest.com
63102 Completed A single, rising dose study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A in healthy male and female elderly volunteers
63103 Completed A repeated rising-dose, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A administered for 7 consecutive days to healthy male and female elderly volunteers
63105 Completed A study to evaluate safety, tolerability and pharmacokinetics of 2, 4, 6, 12, 16,18, and 20 mg of the pentasaccharide Org31540/SR90107A, administered as a single intravenous bolus injection to healthy elderly subjects
63106 Completed A four-period cross-over study to assess the absolute bioavailability, safety and tolerability of the pentasaccharide Org31540/SR90107A, after single dose subcutaneous administration of 2, 4 and 8 mg compared with 4 mg intravenous administration to healthy elderly subjects
63107 Completed Study to Assess the Safety/Tolerability and the Pharmacokinetics/Pharmacodynamics of Org31540/SR90107A Administered As A Single Intravenous Bolus Injection to Healthy Volunteers and Patients with Impaired Renal Function
63108 Completed An interaction study with subcutaneously administered Org31540/SR90107A and oral warfarin in healthy male volunteers (Protocol 63108)
63109_B Completed Interaction study with Org31540/SR90107A and piroxicam in healthy male volunteers
63113 Completed A randomized, assessor-blind, dose reducing, phase II study to assess the safety and efficacy of 10, 8, 6 and 4 mg Org31540/SR90107A and standard treatment with intravenous fragmin in patients with chronic intermittent haemodialysis
63118 Completed European Pentasaccharide Hip Elective Surgery Study (EPHESUS): A multicenter, randomized, double-blind comparison of once daily subcutaneous Org31540/SR90107A with enoxaparin for the prevention of deep vein thrombosis or symptomatic pulmonary embolism in patients undergoing elective hip replacem ...
63119 Completed A double blind, randomized, controlled, dose ranging study of Org31540/SR90107A in patients with unstable angina pectoris: PENTUA
63123 Completed A multicentre, randomized, open-label study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus adjusted dose intravenous (i.v.) unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE) (MATISSE-PE)
63128 Completed A phase I interaction trial to investigate the pharmacodynamics and pharmacokinetics of 10 mg subcutaneous Org31540/SR90107A and intravenous recombinant Factor VIIa, in healthy male volunteers.
63132 Completed A phase I trial to evaluate and compare the safety, pharmacokinetics and pharmacodynamics of a single dose of 7.5mg subcutaneous Org31540/SR90107A in subjects with moderate hepatic impairment and subjects with normal liver function
675187/001 Completed A Phase II, open, randomized, controlled study to evaluate the reactogenicity and safety of an investigational vaccination regimen in healthy toddlers aged 24-30 months. Study Listed on ClinicalStudyDataRequest.com
683699/003 Completed A Randomised, Double-blind, Placebo-controlled, Parallel Group, dose ranging study to investigate the efficacy and safety of three months administration of SB-683699 (150 - 1200mg twice daily) in subjects with relapsing multiple sclerosis
684289/001 Completed A phase IV, open, randomised study in adults aged 18-60 and over 60 years to evaluate the immunogenicity and the reactogenicity of GlaxoSmithKline Biologicals' Fluarix™ vaccine administered using two different routes Study Listed on ClinicalStudyDataRequest.com
701464/005 Completed A phase III, open, controlled, randomised study in adults aged 18-60 and elderly aged over 60 years to confirm the immunogenicity and the reactogenicity of GlaxoSmithKline Biologicals' investigational influenza vaccine Study Listed on ClinicalStudyDataRequest.com
710158/002 Completed A primary vaccination study to evaluate immunogenicity, safety and reactogenicity of 3 doses of GSK Biologicals/Finlay’s meningococcal B candidate vaccine given intramuscularly using either 0-2-4 month or 0-1-6 month schedule to healthy subjects aged 12-18 years Study Listed on ClinicalStudyDataRequest.com

 

 

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GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.

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