Trials / Completed
CompletedNCT00440297
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 277 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Comparator: modified process hepatitis B vaccine | Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
| BIOLOGICAL | Comparator: ENGERIX-B™ | ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2007-02-27
- Last updated
- 2017-04-13
- Results posted
- 2009-07-08
Source: ClinicalTrials.gov record NCT00440297. Inclusion in this directory is not an endorsement.