Status:
COMPLETED
Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B
Eligibility:
All Genders
4-8 years
Phase:
PHASE3
Brief 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 ser...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
1478 Patients enrolled
Trial Details
Trial ID
NCT00393523
Start Date
September 1 2006
End Date
June 1 2008
Last Update
April 12 2017
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