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Study ID Status Title Patient Level Data
208109/085 Completed A randomized, controlled, double-blind field efficacy trial of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine using a recombinant DNA hepatitis B vaccine, Engerix®-B as control.
208109/127 Completed Open study of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine administered to hemophiliac patients.
208109/139 Completed Evaluation of the safety and immunogenicity of a Hepatitis A Vaccine in Patients with Chronic Viral Hepatitis B and C and chronic liver disease of other etiology.
208109/141 Completed A pilot open group study to compare the immunogenicity, reactogenicity and safety of a standard course of hepatitis A vaccine in: HIV positive individuals with haemophilia, HIV negative individuals with haemophilia, HIV negative healthy adult male controls.
208109/145 Completed A study to assess the immunogenicity and reactogenicity of hepatitis A vaccine administered subcutaneously to patients with congenital coagulation disorders using a single primary dose and a booster at six months at a dose of 1440 ELU (in 1 ml) to adults and 720 ELU (in 0.5 ml) to children.
208109/166 Completed A double-blind, randomized, placebo controlled study to evaluate the safety and immunogenicity of Havrix( in subjects with human immunodeficiency virus (HIV) infection
208109/188 Completed Study in healthy 2-month old infants to evaluate immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ inactivated hepatitis A vaccine injected at the age of 2, 4 and 6 months
208109/206 Completed An open multicentric post-marketing surveillance study of the inactivated hepatitis A vaccine (Havrix™), injected according to the prescribing information enclosed, in healthy children and adults.
208109/208 Completed Drug use surveillance of Havrix® (Hepatitis A vaccine) in Korea
208109/210 Completed A Phase 4, open, comparative, multicenter study of the immunogenicity and safety of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine (Havrix) 720 EL.U/ 0.5 ml on a 0, 6-month schedule, administered by intramuscular injection, either to children aged (1) 15 to 18 months old or (2) 11 to 13 months old, when compared to 23 to 25 month-old children; and to determine the immune responses following co-administration of routine childhood vaccines, DTPa and Hib in the 15 to 18 month age group Study Listed on ClinicalStudyDataRequest.com
208109/220 Completed A Phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of GSK Biologicals' inactivated hepatitis A vaccine administered on a 0-6 mth schedule concomitantly with Wyeth Lederle's pneumococcal conjugate vaccine in healthy children 15 months of age Study Listed on ClinicalStudyDataRequest.com
208109/228 Completed A phase IV open study to assess the anamnestic response to a single intramuscular injection of GSK Biologicals’ hepatitis A vaccine, Havrix™ Junior in healthy adult subjects who have had a previously documented seropositive status following a full course of primary vaccination with GSK Biologicals’ hepatitis A vaccine Study Listed on ClinicalStudyDataRequest.com
208109/229 Completed A Phase IIIb, open, multicenter study of the immunogenicity and safety of one dose of GSK Biologicals' inactivated hepatitis A vaccine administered to healthy children who were seropositive for anti-HAV Study Listed on ClinicalStudyDataRequest.com
208109/231 Completed Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age Study Listed on ClinicalStudyDataRequest.com
208109/232 Completed Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 months of Age Study Listed on ClinicalStudyDataRequest.com
208127/ 114 Completed A phase II, open, randomised, multicentric study to compare the immunogenicity, reactogenicity and safety of experimental vaccines to that of Twinrix (administered following a 3 dose schedule (0, 1, 6 months) in healthy adults aged 18-40 years. Study Listed on ClinicalStudyDataRequest.com
208127/021 Completed A double blind randomized, comparative study of the immunogenicity and reactogenicity of three different lots of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B vaccine when administered in healthy adults.
208127/049 Completed An open randomized study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with commercially available hepatitis A and hepatitis B vaccines of SmithKline Beecham Biologicals, when injected in healthy adult volunteers
208127/076 Completed An open study to evaluate the immunogenicity, safety, and reactogenicity of SmithKline Beecham Biologicals’ commercially available combined hepatitis A/hepatitis B vaccine containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, administered following a 2 dose schedule in healthy children
208127/082 Completed Phase III, open, randomised study, in two centers, to demonstrate the equivalence of the 0-12 month schedule to the 0-6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B vaccine Twinrix™ in healthy volunteers (12-15Y)
208127/084 Completed An open, randomised study to compare the immunogenicity, safety and reactogenicity of SmithKline Beecham combined hepatitis A/hepatitis B vaccine Twinrix administered following a 2 dose schedule (0-6 mths) to that of Twinrix. Junior administered following a 3 dose schedule (0, 1, 6 months) in healthy volunteers aged 12-15 years
208127/085 Completed An open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B vaccine when administered, in opposite limbs, with SmithKline Beecham Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with Haemophilus influenzae type b conjugate vaccine
208127/087 Completed An open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitits B vaccine when administered following a 2 dose schedule (0-6 month) and for the first dose, in opposite limbs at month 0, with SmithKline Beecham Biologicals’ measles-mumps-rubella vaccine to healthy children
208127/091 Completed A phase IV, open, randomized, controlled, comparative, multicenter U.S. study of the safety of GSK Biologicals' combination hepatitis A and hepatitis B vaccine administered on a 0-1-6 mth schedule by intramuscular injection compared with concurrently administered monovalent vaccines in healthy adults Study Listed on ClinicalStudyDataRequest.com
208127/097 Completed An open, randomized, monocentric study to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with hepatitis A and hepatitis B vaccines of Chiron Behring/Aventis Pasteur in healthy adult volunteers 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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