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Study ID Status Title Patient Level Data
103388 Completed Blinded, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella candidate vaccine given to healthy children during the second year of life Study Listed on ClinicalStudyDataRequest.com
103413 Completed An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction. Study Listed on ClinicalStudyDataRequest.com
103414 Completed A multicenter, randomized, double-blind, parallel group trial to demonstrate the efficacy of fondaparinux sodium in association with Intermittent Pneumatic Compression (IPC) versus IPC used alone for the prevention of venous thromboembolic events in subjects at increased risk undergoing major abdomi Study Listed on ClinicalStudyDataRequest.com
103420 Completed An international, randomized, double-blind study evaluating the efficacy and safety of fondaparinux versus enoxaparin in the acute treatment of unstable angina/non ST-segment elevation MI acute coronary syndromes Study Listed on ClinicalStudyDataRequest.com
103447 Completed A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Study Listed on ClinicalStudyDataRequest.com
103471 Completed A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500ug via DPI), and , tiotropium bromide (18ug via DPI) in healthy male subjects Study Listed on ClinicalStudyDataRequest.com
103477 Completed A phase IIIb, partially blind, randomized, placebo-controlled study to asses the effect on immunogenicity of administration of vaccine without buffering agent and to assess heat stability in terms of immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus (HRV) vaccine following a 0, 2 month schedule, in healthy infants previously uninfected with human rotavirus Study Listed on ClinicalStudyDataRequest.com
103478 Completed Assess the immunogenicity, safety & reactogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (6-12 weeks of age at first dose) previously uninfected with human rotavirus Study Listed on ClinicalStudyDataRequest.com
103488 Completed A randomized, controlled, phase II study to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age Study Listed on ClinicalStudyDataRequest.com
103514 Completed Phase 3, open, age-stratified study to assess immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine administered intramuscularly according to 3-dose schedule (0,1,6 months) in healthy female subjects aged 15 - 55 years and long term follow-up Study Listed on ClinicalStudyDataRequest.com
103533 Completed Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Study Listed on ClinicalStudyDataRequest.com
103629 Completed An open-label, randomized, 3-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® and a TREXIMA tablet followed by IMI Study Listed on ClinicalStudyDataRequest.com
103812 & 104727 Completed Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine.
103813 Completed A phase III, randomized, multinational study, double-blinded for the immunogenicity and consistency evaluation of 3 Hib-MenCY-TT vaccine lots and single-blinded and controlled for the evaluation of safety and immunogenicity of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (Hib-MenCY-TT) compared to monovalent Hib vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age. Study Listed on ClinicalStudyDataRequest.com
103860/269 Completed Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Study Listed on ClinicalStudyDataRequest.com
103860/271 Completed Immunogenicity and protective efficacy of GlaxoSmithKline (GSK) recombinant-DNA hepatitis B vaccine (10 (g) in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group. Study Listed on ClinicalStudyDataRequest.com
103860/275 Completed Phase II study to compare immunogenicity, reactogenicity and safety of 3 different experimental formulations of GSK Biologicals’ hepatitis B vaccine compared to that of Engerix™-B administered following a 3 dose schedule (0, 1, 6 months) in healthy adults aged 18-40 years. Study Listed on ClinicalStudyDataRequest.com
103860/277 Completed Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Study Listed on ClinicalStudyDataRequest.com
103860/282 Completed Phase III study to evaluate immunogenicity, reactogenicity and safety of GSK preservative free Engerix™-B comparing aged lot and, as reference, new lot when admind intramuscularly according to a 0,1,6 month schedule in healthy volunteers Study Listed on ClinicalStudyDataRequest.com
103860/283 Completed Phase IV study to demonstrate the non-inferiority in terms of immunogenicity of multidose ENGERIX-B with 2-phenoxyethanol as preservative to that elicited by multidose ENGERIX™-B with thiomersal as preservative, when administered according to a 0, 1, 6 month schedule in healthy adults Study Listed on ClinicalStudyDataRequest.com
103860-115 Completed Immunogenicity and protective efficacy of GlaxoSmithKline (previously SmithKlineBeecham) Biologicals’ hepatitis B vaccine (10mcg) in newborn of HBeAg and HBsAg positive mothers compared with a historical control group. Study Listed on ClinicalStudyDataRequest.com
103860-270 Completed Phase III study to evaluate the safety and consistency of 3 consecutive lots of GSK Biologicals’ thiomersal-free Engerix-B™ vaccine containing 20 µg of hepatitis B surface antigen (HbsAg) per 1 ml dose, when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Study Listed on ClinicalStudyDataRequest.com
103880 Completed An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Study Listed on ClinicalStudyDataRequest.com
103933 Completed A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Study Listed on ClinicalStudyDataRequest.com
103954 Completed Study to evaluate the safety, reactogenicity & immunogenicity of a booster dose of GSK Biologicals’ Hib-MenC given with Priorix™, vs Hib-MenC or Priorix™ only, in toddlers (13–14 m) primed with 3 doses of Hib (as part of a DTPa –containing vaccine) & MenC-CRM197 conjugate vaccines. 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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