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Study ID Status Title Patient Level Data
208355/125 Completed A phase III, open, multicenter study of the safety of Infanrix® when administered as a booster dose at 15 to 18 months of age following primary immunization in studies 217744/084 and 217744/085 (Subjects from DTaP-HepB-IPV-084 and DTaP-HepB-IPV-085)
208355/128 Completed Evaluation of safety and efficacy through Post Market Surveillance for Infanrix™, the DTaP mixed vaccine Study Listed on ClinicalStudyDataRequest.com
209762/136 Completed A phase III, blinded, randomized, multicenter U.S. study evaluating the clinical consistency of three production lots of SmithKline Beecham Biologicals' MMR vaccine (PRIORIX) and comparability of PRIORIX with Merck's M-M-R II vaccine, administered to healthy children 12 to 18 months of age Study Listed on ClinicalStudyDataRequest.com
209762/145 Completed
209762/147 Completed Phase IV open study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ live attenuated Measles-Mumps-Rubella (MMR) vaccine when given to healthy children at the age of 12 to 18 months in Singapore. Study Listed on ClinicalStudyDataRequest.com
209762/148 Completed Phase II, double blind, randomized sequential study to compare immunogenicity and reactogenicity of the current formulations of GSK Biologicals’ measles-mumps-rubella vaccine and GSK Biologicals’ varicella vaccine containing human serum albumin with the modified formulations which do not contain HSA Study Listed on ClinicalStudyDataRequest.com
209762/150 Completed Double blind, randomized sequential study to compare immunogenicity and reactogenicity of current formulations of GSK Biologicals’ measles-mumps-rubella vaccine and GSK Biologicals’ varicella vaccine to investigational vaccination regimens Study Listed on ClinicalStudyDataRequest.com
209762/151 Completed Phase II study to evaluate immunogenicity, reactogenicity and safety of GSK Biologicals’ investigational vaccination regimen compared to the currently licensed GSK Biologicals’ Priorix™ and Merck and Co.’s M-M-R®II vaccines when administered as a primary vaccination to healthy children aged 12-24 months Study Listed on ClinicalStudyDataRequest.com
210602-002 Completed Assess the feasibility of an investigational vaccination regimen, compared to a 3-dose primary vaccination with GSK Biologicals' Infanrix hexa™ (DTPa-HBV-IPV/Hib vaccine) following hepatitis B vaccination at birth. Primary vaccination is followed in the 2nd year of life by a booster dose of Infanrix-hexa Study Listed on ClinicalStudyDataRequest.com
213501/016 Completed A post-marketing surveillance study of GlaxoSmithKline (GSK) Biologicals Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B vaccine (TRITANRIX-HB) and Haemophilus influenzae type-b tetanus-conjugate (Hib) vaccine (HIBERIX)co-administered in the same syringe in 1,000 Filipino subjects. Study Listed on ClinicalStudyDataRequest.com
213501/018 Completed Study to evaluate immunogenicity, safety and reactogenicity of two different immunization regimens against hepatitis B, diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib)diseases in healthy infants primed with a birth dose of GSK Biologicals hepatitis B Study Listed on ClinicalStudyDataRequest.com
213501/019 Completed Study to assess immunogenicity and reactogenicity of GSK Biologicals’ quadrivalent diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus influenzae type b conjugate vaccines when mixed extemporaneously and given in a single injection to healthy infants Study Listed on ClinicalStudyDataRequest.com
213503/044 Completed Open study to assess the immunogenicity after two and three doses of GSK Biologicals’ Hib vaccine combined with GSK Biologicals’ DTPa-IPV vaccine given to Swedish infants in a 3, 5, 12 month schedule Study Listed on ClinicalStudyDataRequest.com
213503/045 Completed Study to compare immunogenicity and reactogenicity of GSK Bio’s DTPa-IPV vaccine, with GSK Bio’s DTPa (Infanrix) and Aventis MSDs IPV vaccine (Imovax Polio) administered separately to healthy children 4 to 6 years of age Study Listed on ClinicalStudyDataRequest.com
213503/046 Completed Open, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTaP-IPV vaccine, with GSK Biologicals’ DTaP and Aventis Pasteur MSD’s IPV vaccines administered to healthy children, previously vaccinated with 4 doses of DTaP and polio vaccines, and co-administered with GSK Biologicals’ MMR vaccine Study Listed on ClinicalStudyDataRequest.com
213503/047 Completed Open, randomized, phase II, clinical trial to compare the immunogenicity and safety of a booster dose of GSK Biologicals' DTaP-IPV vaccine (Infanrix®-IPV) co-administered with a booster dose of Merck and Company's M-M-R®II, to that of separate injections of GSK Biologicals' DTaP vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II administered as booster doses to healthy children 4 to 6 years of age. Study Listed on ClinicalStudyDataRequest.com
213503/048 Completed Safety, immunogenicity&consistency of 3 manufacturing lots of DTaP-IPV vaccine vs separate injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV admd as booster doses to healthy children 4-6 yrs, each co-admd with Merck's MMR vaccine Study Listed on ClinicalStudyDataRequest.com
213503/049 Completed An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of GSKBiologicals combined Infanrix-IPV+Hib (DTPa-IPV/Hib) vaccine in healthy children aged 17 to 20 months whocompleted a three-dose primary vaccination course Study Listed on ClinicalStudyDataRequest.com
213503/050 Completed Study to evaluate safety and immunogenicity of a booster dose of DTPa-IPV/Hib at 18 months of age with GSK Biologicals DTPa-IPV/Hib compared to Aventis Pasteurs Pentacel, after an initial primary vaccination series administered at 2, 4, and6 months of age with Aventis Pasteurs Pentacel
217744/025 Completed
217744/049 Completed Immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines when administered concomitantly to healthy infants administered as a three-dose primary vaccination course at the age of 1.5, 3.5 and 6 months Study Listed on ClinicalStudyDataRequest.com
217744/060 Completed Study to assess the immunogenicity and reactogenicity of DTPa-HBV-IPV mixed with Hib vaccine in healthy infants, followed by a dose of the same vaccine administered simultaneously with one dose of oral polio vaccine (OPV) Study Listed on ClinicalStudyDataRequest.com
217744/061 Completed A phase II, single-blinded, randomized comparative study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals' DTPa-HBV-IPV vaccine compared with Infanrix™ when both vaccines are co-administered with OmniHIB™ between 15 and 18 months of age following primary immunization at the age of 2, 4 and 6 months in the study DTPa-HBV-IPV-044 (217744/044) Study Listed on ClinicalStudyDataRequest.com
217744/063 Completed Open, clinical study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine (DTPa-HBV-IPV) administered mixed in the same syringe with GSK Biologicals’ Haemophilus influenzae type b (Hib), tetanus conjugate vaccine in the 3rd and 5th month of life healthy infants, followed at the 11th month of life by a dose of the same GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines mixed in the same syringe and administered simultaneously with one dose of oral poliovirus vaccine Study Listed on ClinicalStudyDataRequest.com
217744/066 Completed Open, randomized, multicentre, phase III clinical trial to assess the reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, co-administered during the same visit with GSK Biologicals’ HAV vaccine (Havrix™), in children in their second year of life. 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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