Trials / Completed
CompletedNCT00985426
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 521 (actual)
- Sponsor
- Dynavax Technologies Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HEPLISAV-B | Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24 |
| BIOLOGICAL | Engerix-B | Intramuscular (IM) injections at Weeks 0, 4, 8, and 24 |
| OTHER | Placebo | Placebo(saline) intramuscular (IM) injection at Week 8 |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2009-09-28
- Last updated
- 2021-05-19
- Results posted
- 2020-12-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00985426. Inclusion in this directory is not an endorsement.