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Study ID Status Title Patient Level Data
25000/643 Completed A bioequivalence study to compare the currently marketed formulation of augmentin with the ES 600 Strawberry Cream Suspension (4A) Study Listed on ClinicalStudyDataRequest.com
25000/654 Completed A Phase III open-label, non-comparative study of BRL25000 ES-600 in paediatric patients with otitis media
25000/665 Completed An open-label, randomized, period balanced, replicate, four-period crossover bioequivalence study comparing AUGMENTIN ES-600 strawberry cream formulation to the marketed suspension. Study Listed on ClinicalStudyDataRequest.com
25000/668 Completed An uncontrolled, phase I study to determine ex vivo the serum bactericidal activity against Streptococcus pneumoniae with decreased susceptibility to amoxicillin in the presence of factors of non-specific immunity with and without specific antibodies, the urine bactericidal activity against Escherichia coli w
257049/005 Completed Phase IIb controlled randomised double-blind study to evaluate the efficacy, safety and immunogenicity of SmithKline Beecham Biologicals’ candidate RTS,S malaria vaccine in semi-immune adult males in The Gambia.
257049/015 Completed Staggered study to evaluate safety and immunogenicity of GSK Biologicals RTS,S/AS02 candidate malaria vaccine, administered intramuscularly according to a 0,1,3-month schedule in semi-immune children aged 6 to 11 years in Gambia, a malaria endemic region
257049/020 Completed Staggered study to evaluate safety & immunogenicity of GSK Biologicals RTS,S/AS02 candidate malaria vaccine, administered intramuscularly according to 0,1,3-month schedule in toddlers and children aged 1 through 5 years in Gambia, a malaria endemic region
257049/025 Completed A phase I, double-blind, randomized, controlled, study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate vaccine, administered intramuscularly according to a 0, 1, 2-month vaccination schedule in children aged 1 through 4
257049/026 Completed A study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ candidate malaria vaccine RTS,S/AS02A, administered intramuscularly according to a 0, 1 and 2 month vaccination schedule in toddlers and children aged 1 to 4 years in a malaria-endemic region of Mozambique. Study Listed on ClinicalStudyDataRequest.com
257049/027 Completed Double-blind, randomized phase I/IIa human challenge study, to evaluate the safety, reactogenicity, immunogenicity, and preliminary efficacy after primary sporozoite challenge and rechallenge, of GSK Biologicals’ candidate malaria vaccines containing the antigen RTS,S adjuvanted with either AS02A or AS01B and administered intramuscularly at months 0, 1, 2 in healthy malaria-naive volunteers aged 18 - 45 years
257049/034 Completed A bridging study to evaluate the safety and immunogenicity of GSK Biologicals’ candidate vaccines RTS,S/AS02D (0.5 mL dose) and RTS,S/AS02A (0.25 mL dose) administered according to a 0, 1, 2 month vaccination schedule in children aged 3 to 5 years living in a malaria-endemic region of Mozambique.
26090/007 Completed A Double-Blind Placebo Controlled Study to Compare Paroxetine with Maprotiline in the Treatment of Depression Study Listed on ClinicalStudyDataRequest.com
263855/001 Completed Single-blind, randomised clinical study to assess and compare the immunogenicity and reactogenicity of the SB Biologicals dTpa, Pa and pa vaccines, and 2 commercial Td vaccines when administered as a booster dose to healthy adolescents, previously vaccinated with the DTP whole cell vaccine (DTPw)
263855/002 Completed Single-blind, clinical study of the immunogenicity and reactogenicity of SB Biologicals’ dTpa, pa vaccines and a Td vaccine, given as a booster dose to healthy adults, from the age of 18 years onwards
263855/004 Completed Randomised clinical study of the consistency of three lots of SB Biologicals dTpa vaccine in terms of immunogenicity and reactogenicity, and of the immunogenicity and reactogenicity of SB Biologicals pa vaccine and Lederle’s Td vaccine when administered as a booster dose to healthy adolescents (10-14 years old)
263855/012 Completed Single-blind clinical study of the immunogenicity and reactogenicity of GSK Biologicals dTpa, pa vaccines and a Tdvaccine, given as a booster dose to healthy adults, from the age of 18 years onwards
263855/014 Completed A phase III, double-blind, randomized, single vaccination study of SmithKline Beecham Biologicals’ reduced antigen content diphtheria-tetanus-acellular pertussis and combined diphtheria-tetanus-whole cell Bordetella pertussis vaccines in healthy children.
263855/017 Completed Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals dTpa vaccine or GSKBiologicals pa vaccine and Lederles Td vaccine at 10 to 14 years of age in study 263855/004 (EXT: dTpa-004) Study Listed on ClinicalStudyDataRequest.com
263855/019 Completed Open, non-randomized, phase IV study to evaluate immunogenicity and safety of GSK Biologicals’ dTpa vaccine when administered as single dose to healthy adolescents in their 11th to 18th year of life who were not previously vaccinated against pertussis and have anti-PT antibody titers < 20 EL.U/ml  Study Listed on ClinicalStudyDataRequest.com
263855/020 Completed An open, phase III, single center study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ dTpa vaccine administered as a single-dose booster in healthy adults aged ≥ 18 years. Study Listed on ClinicalStudyDataRequest.com
263855/028 Completed Single-blind, randomized, phase IV clinical trial to compare the immunogenicity of GSK Biologicals’ dTpa vaccine (Boostrix™) and Aventis Pasteur MSD’s tetanus toxoid vaccine (Tetavax®), ten days after vaccination of healthy adults 18 years of age and older Study Listed on ClinicalStudyDataRequest.com
263855/029 Completed Observer-blind, randomized, phase II clinical trial to assess the immunogenicity and safety of one dose of three formulations of GSK Biologicals’ dTpa vaccine containing 0.5 mg, 0.3 mg and 0.133 mg of aluminum, respectively in healthy adolescents aged 10 to 18 years Study Listed on ClinicalStudyDataRequest.com
263855/033 Completed Double-blind, randomised phase IIIb, study to compare the immunogenicity and reactogenicity of GSK Biologicals DTPa vaccine (Infanrix™) with GSK Biologicals dTpa (Boostrix™) administered to healthy children 4-6 years of age, having experienced an injection site reaction following the 4th dose of Infanrix™ vaccine Study Listed on ClinicalStudyDataRequest.com
263855/034 Completed Double-blind, randomized, phase III clinical trial to evaluate the immunogenicity and reactogenicity of three consecutive doses of dTpa, or of dTpa-IPV followed by two doses of Td vaccine , and compared to three consecutive doses of Td vaccine administered to healthy adults in a 0,1,6-month schedule Study Listed on ClinicalStudyDataRequest.com
263855/035 Terminated Phase IIIb study to evaluate immunogenicity, antibody persistency and reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX vaccines administered to healthy children previously primed with 3 doses of DTPa vaccine compared to placebo (HAVRIX®JUNIOR) 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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