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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant); Biological: Comparator: ENGERIX-B™ (currently licensed product); Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440531

2007_516

V232-059

Details and patient eligibility

About

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™).

Enrollment: 540 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 3 patient groups

1

Active Comparator group

Description:

RECOMBIVAX HB™

Treatment:

Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)

2

Experimental group

Description:

Modified Process Hepatitis B Vaccine

Treatment:

Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)

3

Active Comparator group

Description:

ENGERIX-B™

Treatment:

Biological: Comparator: ENGERIX-B™ (currently licensed product)