Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)

Condition(s) targeted: Hepatitis B Virus Infection

Intervention: Comparator: modified process hepatitis B vaccine (Biological); Comparator: ENGERIX-B™ (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients

Official title: A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7

The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9

The Total Number of Participants With One or More Injection-Site Adverse Experiences

The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C

The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Starting date: December 2006
Last updated: October 29, 2014