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A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)

Primary Purpose

Measles

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
V205C, measles, mumps, and rubella virus vaccine live
Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles focused on measuring Prevention of Measles

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy children 12 to 18 months of age. Exclusion Criteria: Previous receipt of measles, mumps, rubella and/or varicella vaccine. Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster. Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy. History of seizures (convulsions) Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin. A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Antibody response rate to measles at 6 weeks postvaccination

    Secondary Outcome Measures

    Geometric mean titers to measles by ELISA at 6 weeks postvaccination

    Full Information

    First Posted
    April 26, 2005
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00109278
    Brief Title
    A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
    Official Title
    A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    May 2005 (Actual)
    Study Completion Date
    May 2005 (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 test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).
    Detailed Description
    The duration of treatment is 6 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Measles
    Keywords
    Prevention of Measles

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1100 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    V205C, measles, mumps, and rubella virus vaccine live
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
    Primary Outcome Measure Information:
    Title
    Antibody response rate to measles at 6 weeks postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric mean titers to measles by ELISA at 6 weeks postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy children 12 to 18 months of age. Exclusion Criteria: Previous receipt of measles, mumps, rubella and/or varicella vaccine. Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster. Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy. History of seizures (convulsions) Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin. A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).
    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

    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

    A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)

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