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