Status:
COMPLETED
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 h...
Eligibility Criteria
Inclusion
- Healthy male and female older adults greater than or equal to 50 years of age
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00440531
Start Date
November 1 2006
End Date
November 1 2007
Last Update
April 13 2017
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