A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody.
Sponsor: GlaxoSmithKline
Listed as NCT00291980, this PHASE3 trial focuses on Hepatitis B and remains completed. Sponsored by GlaxoSmithKline, it has been updated 6 times since 2006, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Mar 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- GlaxoSmithKline
- Henogen
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aalst, Belgium , Ath, Belgium , Baudour, Belgium , Brussels, Belgium , Charleroi, Belgium , Debrecen, Hungary , Edegem, Belgium , Eger, Hungary , Esztergom, Hungary , Ghent, Belgium and 15 more locations