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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Comparator: Modified Process Hepatitis B Vaccine
* Biological: Comparator: Comparator: ENGERIX-B


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)<br>Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose). | Biological: Comparator: Modified Process Hepatitis B Vaccine<br>* Single dose 5 µg/0.5ml modified process hepatitis B vaccine<br>|
| Active Comparator: 10 µg ENGERIX-B™ Booster (Group 2)<br>Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose) | Biological: Comparator: Comparator: ENGERIX-B<br>* Single dose 10 µg/0.5ml ENGERIX-B<br>|
| Active Comparator: 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)<br>Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose). | Biological: Comparator: Modified Process Hepatitis B Vaccine<br>* Single dose 5 µg/0.5ml modified process hepatitis B vaccine<br>|
| Active Comparator: 10 µg ENGERIX-B™ Booster (Group 4)<br>Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose). | Biological: Comparator: Comparator: ENGERIX-B<br>* Single dose 10 µg/0.5ml ENGERIX-B<br>|
| Experimental: 5 µg Modified Process Hepatitis B Vaccine (Group 5)<br>Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine. | Biological: Comparator: Modified Process Hepatitis B Vaccine<br>* Single dose 5 µg/0.5ml modified process hepatitis B vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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™. | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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™. | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |