Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

Phase 3

Completed

• Conditions: Hepatitis B

• Registration Number: NCT00440531
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2008-11-11
• Results First Submitted QC: 2009-02-27
• Results First Posted: 2009-03-31
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Healthy male and female older adults greater than or equal to 50 years of age

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Exclusion Criteria

• Any adult with a history of previous hepatitis B infection
• A history of vaccination with any hepatitis B vaccine
• Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
• Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
• 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
• Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
• Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
• Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
• Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
• Pregnant women, nursing mothers, and women planning to become pregnant within the study period
• Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)	7 months (1 month after third vaccination)	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 vaccination) and at Month 7 (1 month after the third vaccination).

Secondary Outcome Measures

Name	Time	Method
The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)	7 months (1 month after third vaccination)	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 vaccination) and at Month 7 (1 month after the third vaccination).
The Total Number of Participants With One or More Injection-site Adverse Experiences	Days 1-5 After Any Vaccination
The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C	Day 1-5 After Vaccination
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences	During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)