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Study ID Status Title Patient Level Data
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
103860-046 Completed Assessment of the clinical acceptability, immunogenicity and long-term preventive efficacy of GlaxoSmithKline (previously SmithKline Beecham and SmithKline-Rit) Biologicals’ recombinant DNA anti-hepatitis B vaccine in hemophiliacs.
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
103860-143 Completed Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (previously SmithKline Beecham and SmithKline-Rit) Biologicals’ recombinant DNA hepatitis B vaccine with or without hepatitis B immune globulins (HBIg) in newborns of HBeAg-positive mothers. 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
103967 Completed A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Study Listed on ClinicalStudyDataRequest.com
103974 (primary study) Completed Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Study Listed on ClinicalStudyDataRequest.com
103992 Completed Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Study Listed on ClinicalStudyDataRequest.com
103997 Completed An open, non-comparative study to evaluate the efficacy and safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic acid) po q 12 hours in the treatment of uncomplicated skin and soft tissue infections in Pakistan
104005 Completed Phase IIIb, open, randomized, multicenter study to assess the immunogenicity & safety of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in Indian infants when given at 6-10-14 weeks of age or at 2-4-6 months of age Study Listed on ClinicalStudyDataRequest.com
104020 Completed Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Study Listed on ClinicalStudyDataRequest.com
104021 Completed A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Study Listed on ClinicalStudyDataRequest.com
104033 Completed A 28-day, Randomised, Double-Blind, Active Comparator, Controlled Study to Assess the Effects of Rosiglitazone, Inhaled Corticosteroid, Theophylline and Theophylline Plus Inhaled Corticosteroid on Inflammation and Pulmonary Function in Asthmatic Smokers.
104056 Completed Study to demonstrate the non-inferiority of the meningococcal serogroup C immune response of GlaxoSmithKline Biologicals’ Hib-MenC vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ vaccine Study Listed on ClinicalStudyDataRequest.com
104065 Completed Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Study Listed on ClinicalStudyDataRequest.com
104124 Completed Assess the safety and reactogenicity of GSK Biologicals Hib vaccine co-administered with Chinese local DTPw vaccine when compared to Chinese local DTPw vaccine administered alone, in healthy infants at 3,4 & 5 months of age
104147 Completed A multicentric, post-marketing surveillance to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals Hepatitis A vaccine administered in Korean population.

 

 

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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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