A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Merck Sharp & Dohme LLC0 sites540 target enrollmentNovember 2006

ConditionsHepatitis B

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 540
Primary Endpoint: The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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™).

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

November 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)

Time Frame: 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 Outcomes

The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)(7 months (1 month after 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))