A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - ND
- Conditions
- Prophylactic vaccination against infection with hepatitis B virus in renal predialysis and dialysis patientsMedDRA version: 9.1Level: LLTClassification code 10038474Term: Renal insufficiency
- Registration Number
- EUCTR2006-003650-20-IT
- Lead Sponsor
- Merck and Co Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 276
1. Male and female predialysis patients (defined as having a creatinine clearance <=30 mL/min as calculated according to the Cockroft-Gault formula) or patients currently receiving either hemodialysis or peritoneal dialysis. 2. Visit 1 (screening visit) blood sample with laboratory confirmed negative result for HBsAg, anti-HBc and anti-HBs. 3. At least 18 years of age. 4. For women, a negative urine pregnancy test just prior to vaccination on visit 2 (day 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. History of previous hepatitis B infection. 2. History of vaccination with any hepatitis B vaccine either alone or in combination. 3. Recent (<72 hours) history of febrile illness (oral temperature >=37.8?C/>=100.0?F). 4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (e.g., aluminum, yeast). 5. Recent administration (within 3 months prior to first injection with the study vaccine)of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood derived product or plans to receive such products within the study period. 6. Receipt of licensed inactivated vaccines within 14 days prior to vaccination with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to vaccination with the study vaccine or plans to receive licensed vaccines within 30 days following each dose of study vaccine. 7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or plans to receive investigational drugs or vaccines within the study period. 8. Known or suspected impairment of immunologic function (other than from renal disease) (e.g., HIV positivity, end-stage liver disease). 9. Recent use (within 3 months prior to first injection with the study vaccine) of systemic immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. 10. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. 11. Currently abusing IV drugs. 12. Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Among dialysis patients and predialysis patients who receive 3 doses of either modified process hepatitis B vaccine or ENGERIX-B, to describe (1 month after the third dose of vaccine) the seroprotection rate (SPR) for the modified process hepatitis B vaccine and ENGERIX-B.;Secondary Objective: - Among dialysis patients and predialysis patients who receive 4 doses of either modified process hepatitis B vaccine or ENGERIX-B, to describe (1 month after the fourth dose of the vaccine) the SPR for the modified process hepatitis B vaccine and ENGERIX-B. - To describe the safety and tolerability of the modified process hepatitis B vaccine in dialysis and predialysis patients.;Primary end point(s): The primary purpose of this study is to estimate the SPR (percent of patients with an anti-HBs titer >= 10 mIU/mL) at 1 month after the third and fourth doses for the modified process hepatitis B vaccine and ENGERIX B
- Secondary Outcome Measures
Name Time Method