A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
NCT ID: NCT00291941
Last Updated: 2008-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2006-02-28
2007-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Henogen HB vaccine
Henogen HBV vaccine
20µg, Month 0, 2 and 6
2
Fendrix vaccine
FENDRIX
20 µg,Months 0, 1, 2 and 6
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Henogen HBV vaccine
20µg, Month 0, 2 and 6
FENDRIX
20 µg,Months 0, 1, 2 and 6
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent obtained from the subject/ from the parent or guardian of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
* Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
* Non-childbearing potential female
Exclusion Criteria
* Use of any registered vaccine within 7 days before the first dose of study vaccine.
* Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 months.
* Use of immunoglobulins within six months preceding the first study vaccination.
* Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
* Any confirmed or suspected human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature \< 37.5°C (or 37 °C in Czech Republic).
* Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
* Pregnant or lactating female
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Henogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henogen
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian Tielemans, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ULB Hôpital Erasme Département de Néphrologie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
O.L.Vrouwziekenhuis Aalst
Aalst, , Belgium
RHMS La Madeleine ATH
Ath, , Belgium
RHMS Clinique Louis Caty Baudour
Baudour, , Belgium
AZ -VUB Dienst Nefrologie
Brussels, , Belgium
Cliniques universitaires Saint Luc
Brussels, , Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, , Belgium
ULB Hôpital Erasme Département de Néphrologie
Brussels, , Belgium
CHU Hôpital civil de
Charleroi, , Belgium
UZ AntwerpenDienst nefrologie
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
CHU Tivoli
La Louvière, , Belgium
UZ Gasthuisberg Leuven Nierziekten
Leuven, , Belgium
CHU Andre VESALE
Montigny-le-Tilleul, , Belgium
RHMS TournayService de néphrologie
Tournai, , Belgium
Dept. of Heamodialysis Hospital JihlavaVrchlického
Jihlava, , Czechia
Regional Hospital Liberec
Liberec, , Czechia
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
Ostrava - Poruba, , Czechia
Dept. of Internal Medicine StrahovSermirska 5
Prague, , Czechia
Masaryk´s Hospital Socialni pece 3316/12A
Ústí nad Labem, , Czechia
St. Rókus Hospital
Budapest, , Hungary
St. István Hospital
Budapest, , Hungary
Petz Aladár Teaching Hospital Vasvári
Győr, , Hungary
Pest County Flór Ferenc Hospital
Kistarcsa, , Hungary
Vas and Szombathely County Markusovszky Hospital
Szombathely, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HN014/HBV-001 (105757)
Identifier Type: -
Identifier Source: org_study_id
NCT00739726
Identifier Type: -
Identifier Source: nct_alias