Clinical trial
A Study to Compare the Immune Response and Safety Elicited by Henogen's…
NCT00291941 · Henogen, Industry · Completed
Key facts
| NCT number | NCT00291941 |
|---|---|
| Title | 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. |
| Official title | A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive. |
| Lead sponsor | Henogen, Industry |
| Collaborators | GlaxoSmithKline Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hepatitis B |
| Intervention type | Biological |
| Interventions | Henogen HBV vaccine, FENDRIX |
| Enrollment | 300 |
| Start date | Feb 1, 2006 |
| Primary completion | Mar 1, 2007 |
| Completion | Mar 1, 2007 |
| First posted | Feb 15, 2006 |
| Last update posted | Aug 28, 2008 |
| Countries | Belgium, Czechia, Hungary |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: