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Hepatitis B clinical trials

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NCT ID: NCT00329576 Completed - Hepatitis B Clinical Trials

Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

Start date: May 2006
Phase: Phase 4
Study type: Interventional

To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

NCT ID: NCT00324961 Completed - Chronic Hepatitis B Clinical Trials

Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B

Start date: January 2006
Phase: Phase 4
Study type: Interventional

This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with HBeAg negative chronic hepatitis B

NCT ID: NCT00322361 Completed - Clinical trials for Hepatocellular Carcinoma

Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Start date: May 2006
Phase: Phase 2
Study type: Interventional

Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce protection against the morbidity and mortality of acute hepatitis B virus infection, [2] reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.

NCT ID: NCT00320463 Completed - Hepatitis B Clinical Trials

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

Start date: April 2006
Phase: Phase 3
Study type: Interventional

In this study, infants will be randomly allocated into three groups: - one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) - the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) - the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

NCT ID: NCT00317187 Completed - Hepatitis B Clinical Trials

Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Start date: June 8, 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

NCT ID: NCT00317174 Completed - Hepatitis B Clinical Trials

A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.

Start date: July 2003
Phase: Phase 2
Study type: Interventional

The purpose of the study is as follows: - To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects. - To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.

NCT ID: NCT00317161 Completed - Hepatitis B Clinical Trials

Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.

Start date: August 2004
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.

NCT ID: NCT00317135 Completed - Hepatitis B Clinical Trials

Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Start date: December 11, 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

NCT ID: NCT00317122 Completed - Clinical trials for Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth

Start date: October 2004
Phase: Phase 3
Study type: Interventional

This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.

NCT ID: NCT00316719 Completed - Chronic Hepatitis B Clinical Trials

Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

Start date: January 2006
Phase: Phase 3
Study type: Interventional

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.