Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine
Hepatitis AA double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®). Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis...
Hepatitis B VaccineThe purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Hepatitis B Vaccination in HIV-infected Persons
HIV InfectionsHepatitis BIn this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in...
Whole Cell PertussisTetanus4 moreThis study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent...
Hepatitis BHepatitis AThe focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge...
Hepatitis BThe purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines...
Hepatitis BHepatitis AThis protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis...
Chronic Hepatitis BThe objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B following liver transplantation, in participants who were chronically infected with hepatitis B prior to transplantation. Prior to enrollment, participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation. Enrolled participants then received FTC/TDF plus HBIg for an initial 24-week pre-randomization treatment period. Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse events and various laboratory parameters.
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly...
DiphtheriaPertussis3 morePR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3. Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar® Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis...
Hepatitis BComparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years