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Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Primary Purpose

Hepatitis B, Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: RECOMBIVAX HB™
Comparator: Modified process Hepatitis B Vaccine
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

1 Day - 10 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age) Born to mothers with documented negative test for HBsAg within 9 months prior to delivery Exclusion Criteria: Infant born to mother with no prenatal care Known or suspected impairment of immunologic function Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.) Recent(<72 hours) history of febrile illness >/= 99.5 degrees F (>/= 37.5 degrees C) axillary or >/= 100.5 degrees F (>/= 38.1 degrees C) rectal Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast) Any infant who cannot be adequately followed for study visits during the course of the clinical study Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Modified Process Hepatitis B Vaccine

    Recombivax HB™

    Outcomes

    Primary Outcome Measures

    Geometric mean titer to hepatitis B surface antigen at Month 7

    Secondary Outcome Measures

    Safety and tolerability including use of Vaccination Report Card

    Full Information

    First Posted
    May 2, 2006
    Last Updated
    March 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00322361
    Brief Title
    Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
    Official Title
    A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (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
    Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce protection against the morbidity and mortality of acute hepatitis B virus infection, [2] reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    566 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Modified Process Hepatitis B Vaccine
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Recombivax HB™
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: RECOMBIVAX HB™
    Intervention Description
    RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Modified process Hepatitis B Vaccine
    Intervention Description
    Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
    Primary Outcome Measure Information:
    Title
    Geometric mean titer to hepatitis B surface antigen at Month 7
    Time Frame
    4 weeks Post Dose 3
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability including use of Vaccination Report Card
    Time Frame
    Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    10 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age) Born to mothers with documented negative test for HBsAg within 9 months prior to delivery Exclusion Criteria: Infant born to mother with no prenatal care Known or suspected impairment of immunologic function Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.) Recent(<72 hours) history of febrile illness >/= 99.5 degrees F (>/= 37.5 degrees C) axillary or >/= 100.5 degrees F (>/= 38.1 degrees C) rectal Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast) Any infant who cannot be adequately followed for study visits during the course of the clinical study Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
    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

    Citations:
    PubMed Identifier
    22227229
    Citation
    Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5.
    Results Reference
    derived
    Links:
    URL
    http://www.merck.com/clinical-trials/policies-perspectives.html
    Description
    Click here to access a synopsis of the study results.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

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