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Hepatitis B Vaccine Booster Study (V232-058)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: Comparator: Modified Process Hepatitis B Vaccine (Biological); Comparator: Comparator: ENGERIX-B (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

Clinical Details

Official title: A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy

Secondary outcome: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy


Minimum age: 4 Years. Maximum age: 8 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy Children 4 to 8 years of age

- Complete medical records documenting receiving a previous hepatitis B vaccination

during the first year of life (for Cohort A and B only)

- Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a

primary series of ENGERIX-B (for Cohort A and B only) Exclusion Criteria:

- Birth mother known to be a carrier of hepatitis B virus (Cohort C only)

- History of previous hepatitis B vaccine

- History of vaccination with any hepatitis B vaccine (Cohort C only)

- Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B

(eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product

- Receipt of investigational drugs or vaccines within 3 months prior to study vaccine

or planned within study period

- Impairment of immunologic function or recent use of immunomodulatory medications

- A Combination of different hepatitis B vaccines used in the primary vaccination

series (Cohort A and B only)

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: September 2006
Last updated: February 26, 2015

Page last updated: August 20, 2015

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