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

Phase 3

Completed

• Conditions: Hepatitis B Virus Infection

• Registration Number: NCT00440297
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-03-24
• Results First Submitted QC: 2009-05-18
• Results First Posted: 2009-07-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7	7 months (1 month after the third dose)	The number of participants as measured by the; seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9	9 months (1 month after the fourth dose)	The number of participants as measured by the; seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose).
The Total Number of Participants With One or More Injection-Site Adverse Experiences	Days 1-15 After Any Vaccination
The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C	Days 1-5 After Any Vaccination
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences	0-9 months (recorded from first dose until the participant completes or discontinues the study)	Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).