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

Merck Sharp & Dohme LLC1,478 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,478

Conditions

Hepatitis B

Interventions

Comparator: Modified Process Hepatitis B VaccineBIOLOGICAL

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

Comparator: Comparator: ENGERIX-BBIOLOGICAL

Single dose 10 µg/0.5ml ENGERIX-B

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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™.

Time frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Secondary Outcomes

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

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™.

Time frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Data from ClinicalTrials.gov

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