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Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen Exclusion Criteria: Problems with immune system Recent illness with fever

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2004
    Last Updated
    October 6, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092469
    Brief Title
    Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
    Official Title
    A Registration Study of the Safety, Tolerability, and Immunogenicity of V441 in Healthy Infants in Taiwan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2002 (undefined)
    Primary Completion Date
    August 2003 (Actual)
    Study Completion Date
    August 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.
    Detailed Description
    The duration of treatment is 65 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    151 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
    Other Intervention Name(s)
    V441
    Primary Outcome Measure Information:
    Title
    Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    8 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen Exclusion Criteria: Problems with immune system Recent illness with fever
    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

    Learn more about this trial

    Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)

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