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

NCT00440297 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2017-04-13

Study results available
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Summary

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

Conditions

  • Hepatitis B Virus Infection

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-05-31
Completion
2008-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440297 on ClinicalTrials.gov