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Study ID Status Title Patient Level Data
208355/022 Completed Double-blind randomised comparative assessment of the immunogenicity and reactogenicity of 3 different lots of SB Bios´ combined diphtheria, tetanus, acellular pertussis vaccine.The vaccine will be admin to healthy infants as a primary vaccination course of 3 consecutive doses at 3-4-5 months of age
208355/050 Completed Prospective Household Contact Study to compare the frequency of clinical pertussis disease following household exposure in children previously vaccinated with a primary course of 3 doses of SB Biologicals combined acellular tricomponent DTPa vaccine and in children not immunized against pertussis
208355/101 Completed Comparative assessment of immunogenicity and reactogenicity of three different production lots of SB Biologicals combined diphtheria, tetanus, tricomponent acellular (PT 25 g + FHA 25 g + PRN 8 g) vaccine administered as a booster dose in healthy 15 to 24 month old children
208355/117 Completed A study of the safety and immunogenicity of initiating a primary vaccination series of DTPa administered at 2, 4, and 6 months of age with Tripedia® and completing the series with Infanrix®
208355/118 Completed Comparative assessment of immunogenicity and reactogenicity of three different production lots of SB Biologicals combined diphtheria, tetanus, tricomponent acellular (PT 25 g + FHA 25 g + PRN 8 g) vaccine administered as a booster dose in healthy 15 to 24 month old children
208355/120 Completed Clinical study of the reactogenicity and immunogenicity of SB Biologicals’ DTPa vaccine administered as a booster to healthy children 4 to 6 years of age, previously vaccinated with four doses of SB Biologicals’ DTPa vaccine in the first two years of life
208355/122 Completed Open prospective clinical study to assess the reactogenicity and immunogenicity of SB Biologicals’ APV vaccine administered as a booster dose to healthy children of 10-11 years of age (11 years included) previously primed with three doses of DTP whole cell vaccine.
208355/123 Completed A phase III, open, multicenter study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals’ Diphtheria and Tetanus toxoids and acellular Pertussis (DTaP) vaccine (Infanrix™) and Pasteur Mérieux’s Haemophilus influenzae type b (Hib) conjugate vaccine (OmniHIB®) when administered intramuscularly as separate injections between 12 and 18 months of age following primary immunization at 2 months, 4 months, and 6 months of age in study DTPa-HBV-IPV-027 (217744/027) Study Listed on ClinicalStudyDataRequest.com
208355/124 Completed An open, 3.5 year, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa vaccine or GSK Biologicals’ DTPa vaccine or Chiron Behring’s Td vaccine + either Pasteur Merieux’s Pa vaccine or GSK Biologicals’ pa vaccine, administered as a booster dose at age 4-6 years in study 208355/118 (APV-118) Study Listed on ClinicalStudyDataRequest.com
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
209762/146 Completed Open, multicentre study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals live attenuated Measles-Mumps-Rubella vaccine (Priorix) given to healthy children at the age of 12 to 15 months or 4- 6 years
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
209762/149 Completed Phase IV, single-blind, randomised, multicenter study to evaluate immediate post-vaccination pain, reactogenicity and tolerance of GSK Biologicals' Measles-Mumps-Rubella vaccine (Priorix) administered as a second dose compared to Aventis-Pasteur-MSDs Measles-Mumps-Rubella vaccine (ROR Vax) 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
209762-145 Completed Phase IV, open, multicentric, post-marketing surveillance study to monitor safety and reactogenicity of GSK Biologicals' live attenuated Measles-Mumps-Rubella vaccine in Korean subjects admind according to the Prescribing Information Study Listed on ClinicalStudyDataRequest.com
21 Completed Six week, parallel, double blind, randomized comparison of bupropion versus amitriptyline (75-225mg/day) in inpatients - Extensive searching has revealed that no clinical study report is available for this study. The clinical trial results were reported via publication; see citations below.
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
213501/021 Completed Study to assess immunogenicity and reactogenicity of GSK Bio’s combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B/Haemophilus influenzae type b vaccine injected in healthy infants previously primed at birth with hepatitis B vaccination.

 

 

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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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