Trials / Completed
CompletedNCT01195246
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
An Open-Label, Randomized, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis Who Have Previously Received Hepatitis B Vaccination and Are Not Seroprotected
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- Dynavax Technologies Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.
Detailed description
The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HEPLISAV | Intramuscular (IM) injection on Day1 |
| BIOLOGICAL | Engerix-B | Intramuscular (IM) injection on Day 1 |
| BIOLOGICAL | Fendrix | Intramuscular (IM) injection on Day 1 |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-02-01
- Completion
- 2012-08-01
- First posted
- 2010-09-06
- Last updated
- 2019-03-20
Locations
19 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01195246. Inclusion in this directory is not an endorsement.