Status:
COMPLETED
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
Eligibility Criteria
Inclusion
- Male and female subjects at least 18 years of age
- Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine
- Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of \<=30 ml/min
Exclusion
- Previous hepatitis B infection, vaccination with any hepatitis B vaccine
- Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines
- Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
- Receipt of investigational drugs or investigational vaccines within 3 months prior
- Impairment of immunologic function
- Recent use of systemic immunomodulatory medications
- Pregnant women, nursing mothers or women planning to become pregnant
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00440297
Start Date
December 1 2006
End Date
May 1 2008
Last Update
April 13 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.