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Result Summaries: Hepatitis A Vaccine, Inactivated

GSK
Study ID
   Phase    Title Summary (Download)
100571 (M138) phase 3 Long-term follow-up study to evaluate the immune persistence of GSK Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per ml and injected according to a 0, 12-month schedule in healthy adult volunteers (2 citation(s)) Click here to download result summary.
100576 (Y11) phase 3 Long term follow-up study to evaluate the immune persistence of GSK Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per ml and injected according to a 0, 6-month schedule in healthy adult subjects (10 citation(s)) Click here to download result summary.
104147 Phase 4 A multicentric, post-marketing surveillance to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals Hepatitis A vaccine administered in Korean population. (1 citation(s)) Click here to download result summary.
104902 Phase 3 Primary and long-term follow-up study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 10-14 years. (6 citation(s)) Click here to download result summary.
104951 phase 3 Evaluate the immunogenicity & safety of GSK Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0,1,6 mth schedule in healthy female subjects aged 10–14 yrs (2 citation(s)) Click here to download result summary.
106208 phase 2 To assess reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) at 2, 4 and 6 months of age. (4 citation(s)) Click here to download result summary.
109563_1 phase 3 COMPAS: A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media (8 citation(s)) Click here to download result summary.
110031_ phase 2 Phase II, observer-blind follow-up study to assess reacto-and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), when given as booster in primed children or as 2-dose catch-up in unprimed children. (2 citation(s)) Click here to download result summary.
110058_1 phase 2 Immunogenicity of GlaxoSmithKline Biologicals' MMRV vaccine (208136) vs. ProQuad®, when coadministered with hepatitis A and pneumococcal conjugate vaccines to children 12-14 months of age. (1 citation(s)) Click here to download result summary.
111442_1 phase 3 Evaluation of effectiveness of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A against invasive disease (4 citation(s)) Click here to download result summary.
111870_ phase 2 Immunogenicity of GlaxoSmithKline Biologicals’ MMR vaccine (209762) vs. M-M-R® II, when co-administered with hepatitis A, varicella and pneumococcal conjugate vaccines to children 12-15 months of age (1 citation(s)) Click here to download result summary.
112158 n\a Epidemiologic surveillance to assess trends in acute hepatitis A among children in Panama (0 citation(s)) Click here to download result summary.
112263 n\a Time trend analysis of the incidence of hepatitis- related outcomes (viral hepatitis A and unspecified viral hepatitis) reported to the Surveillance System of Panama, 2000-2010 (0 citation(s)) Click here to download result summary.
112595_1 phase 3 Impact on nasopharyngeal carriage, acute otitis media, immunogenicity and safety of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A (3 citation(s)) Click here to download result summary.
113564 n\a Sero-prevalence of Hepatitis A Varicella-Zoster virus, Cytomegalovirus, Herpes Simplex and Bordetella pertussis in Mexico (3 citation(s)) Click here to download result summary.
114451__ phase 4 Immunogenicity and safety study of GSK Biologicals’ seasonal (2010-2011) influenza vaccine FluarixTM in children previously vaccinated with GSK Biologicals’ H1N1 vaccine PandemrixTM (1 citation(s)) Click here to download result summary.
114452_2 phase 4 Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM (1 citation(s)) Click here to download result summary.
114541_1 phase 3 Efficacy study of GSK Biologicals’ quadrivalent influenza vaccine, GSK2282512A, (FLU Q-QIV) when administered in children (1 citation(s)) Click here to download result summary.
208109/085 Phase 3 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. (1 citation(s)) Click here to download result summary.
208109/127 Phase 3 Open study of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine administered to hemophiliac patients. (1 citation(s)) Click here to download result summary.
208109/139 Phase 4 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. (1 citation(s)) Click here to download result summary.
208109/141 Phase 4 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. (0 citation(s)) Click here to download result summary.
208109/145 Phase 3 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. (1 citation(s)) Click here to download result summary.
208109/166 Phase 4 A double-blind, randomized, placebo controlled study to evaluate the safety and immunogenicity of Havrix( in subjects with human immunodeficiency virus (HIV) infection (1 citation(s)) Click here to download result summary.
208109/188 Phase 3 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 (1 citation(s)) Click here to download result summary.
208109/206 Phase 4 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. (0 citation(s)) Click here to download result summary.
208109/208 Phase 4 Drug use surveillance of Havrix® (Hepatitis A vaccine) in Korea (0 citation(s)) Click here to download result summary.
208109/210 Phase 4 A Phase 4, open, comparative, multicenter study of the immunogenicity and safety of SB Bios' inactivated hepatitis A vaccine 720 EL.U/ 0.5 ml on a 0-6-month schedule, admin by intramuscular injection, either to children aged 15-18 mths old or 11-13 mths old, when compared to 23-25 mth-old children (1 citation(s)) Click here to download result summary.
208109/220 phase 3 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 (1 citation(s)) Click here to download result summary.
208109/228 Phase 4 A phase IV open study to assess the anamnestic response to a single intramuscular injection of GSK Bios’ hepatitis A vac, Havrix™ Junior in healthy adult subjects who have had a previously documented seropositive status following a full course of primary vaccination with GSK Bios’ hepatitis A vac (2 citation(s)) Click here to download result summary.
208109/229 Phase 3 A Phase IIIb, open, multicenter study of the immunogenicity and safety of one dose of GSK Bios' inactivated hepatitis A vaccine administered to healthy children who were seropositive for anti-HAV (0 citation(s)) Click here to download result summary.
208109/231 phase 3 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 m of Age (1 citation(s)) Click here to download result summary.
208109/232 phase 3 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 (1 citation(s)) Click here to download result summary.
208141/039_ phase 3 A double-blind, randomized, controlled Phase III study to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are HSV-1 and -2 seronegative. (1 citation(s)) Click here to download result summary.
208141/040 phase 3 A study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' herpes simplex candidate vaccine (gD2‑AS04) in healthy HSV seronegative and seropositive female subjects aged 10-17 years. (2 citation(s)) Click here to download result summary.
217744/066 Phase 3 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 ... (0 citation(s)) Click here to download result summary.
270362/002 Phase 3 A phase III open study designed to evaluate the immunogenicity and reactogenicity of a booster dose of Havrix 1440TM in healthy volunteers previously vaccinated with a single dose of SB Biologicals’ combined Vi polysaccharide typhoid and inactivated hepatitis A vaccine. (0 citation(s)) Click here to download result summary.
270362/004 Phase 3 A single-blind, randomized study to evaluate the immunogenicity and reactogenicity of two production lots of GSK Bios’ combined Vi polysaccharide typhoid and inactivated hepatitis A vaccine stored between 2 °C-8 °C for either 0-12 or 24-36 mths and admin as a single dose to healthy adult volunteers (0 citation(s)) Click here to download result summary.
270362/006 phase 3 A phase III, open, randomized, multicentric study to compare the reactogenicity and immunogenicity of GSK Bios’ combined Vi polysaccharide typhoid vac and inactivated hepatitis A vac, to that elicited by GSK Bios’ hepatitis A vac, admin singly or concomitantly with GSK Bios’ Vi polysaccharide vac (0 citation(s)) Click here to download result summary.
347414/010 phase 3 Assess, in young children, the efficacy in preventing acute otitis media (AOM) of GSK Biologicals undecavalent pneumococcal-protein D conjugate vaccine, when administered as a three dose primary vaccination course during the first year of life with a booster dose in the second year of life. (7 citation(s)) Click here to download result summary.
580299/008_ phase 3 Efficacy of GSK Bio HPV Vaccine (580299) vs Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16/18 Cervical Infection & Cervical Neoplasia, administered intramuscularly according to 0,1,6 month Schedule in Healthy Females (15-25 years) (48 citation(s)) Click here to download result summary.
580299/009_1 phase 3 A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica (18 citation(s)) Click here to download result summary.
710158/002 Phase 2 A primary vaccination study to evaluate immunogenicity, safety & reactogenicity of 3 doses of GSK Biologicals/Finlay’s meningococcal B candidate vaccine given intramuscularly using either 0-2-4 mth or 0-1-6 mth schedule to healthy subjects aged 12-18 yrs (1 citation(s)) Click here to download result summary.