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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: Modified Process Hepatitis B Vaccine
Comparator: Comparator: ENGERIX-B
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)

    10 µg ENGERIX-B™ Booster (Group 2)

    5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)

    10 µg ENGERIX-B™ Booster (Group 4)

    5 µg Modified Process Hepatitis B Vaccine (Group 5)

    Arm Description

    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).

    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)

    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).

    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).

    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.

    Outcomes

    Primary Outcome Measures

    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™.

    Secondary Outcome Measures

    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™.

    Full Information

    First Posted
    October 25, 2006
    Last Updated
    March 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00393523
    Brief Title
    Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
    Official Title
    A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1478 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    10 µg ENGERIX-B™ Booster (Group 2)
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    10 µg ENGERIX-B™ Booster (Group 4)
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    5 µg Modified Process Hepatitis B Vaccine (Group 5)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Modified Process Hepatitis B Vaccine
    Intervention Description
    Single dose 5 µg/0.5ml modified process hepatitis B vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Comparator: ENGERIX-B
    Intervention Description
    Single dose 10 µg/0.5ml ENGERIX-B
    Primary Outcome Measure Information:
    Title
    Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
    Description
    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 Outcome Measure Information:
    Title
    Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
    Description
    Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
    Time Frame
    4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
    Title
    Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
    Description
    Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
    Time Frame
    4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    20724955
    Citation
    Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.
    Results Reference
    result

    Learn more about this trial

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

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