Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

Phase 3

Completed

• Conditions: Hepatitis B

• Registration Number: NCT00393523
• Lead Sponsor: Merck Sharp & Dohme LLC

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-27
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-05-27
• Results First Submitted QC: 2009-09-10
• Results First Posted: 2009-10-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1478

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy	4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B	Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.

Secondary Outcome Measures

Name	Time	Method
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy	4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B	Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.