A Study in Renal Predialysis and Dialysis Patients of the Safety,Tolerability, and Immunogenicity of Recombinant Hepatitis BVaccine Manufactured with a Modified Process - Hepatitis B Vaccine (Recombinant) Dialysis Study

Merck & Co Inc.,0 sites276 target enrollmentDecember 17, 2006

ConditionsHepatitis B MedDRA version: 8.1Level: LLTClassification code 10019731Term: Hepatitis B

DrugsENGERIX-B

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: Merck & Co Inc.,
Enrollment: 276
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 17, 2006

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck & Co Inc.,

Eligibility Criteria

Inclusion Criteria

•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.
•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

Exclusion Criteria

•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\.8ºC/\=100\.0ºF).
•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.