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Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
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

Eligibility Criteria

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

Inclusion Criteria: Healthy children 12 to 18 months of age Exclusion Criteria: History or prior exposure to measles, mumps, or rubella History of allergic reactions to any component of the vaccines as evaluated by the study doctor

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination

    Secondary Outcome Measures

    Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination

    Full Information

    First Posted
    September 22, 2004
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092404
    Brief Title
    Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)
    Official Title
    A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured With Recombinant Human Albumin (rHA) Versus V205C Manufactured With Pooled-Donor 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
    December 2001 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 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 trial is to study the safety and immune response to measles, mumps, and rubella in children who were vaccinated with an investigational measles-mumps-rubella live vaccine made with artificially made human protein.
    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, Mumps, Rubella, Varicella

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1210 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    measles, mumps, and rubella virus vaccine live
    Other Intervention Name(s)
    V205C
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
    Primary Outcome Measure Information:
    Title
    Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination
    Time Frame
    6 weeks postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination
    Time Frame
    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: History or prior exposure to measles, mumps, or rubella History of allergic reactions to any component of the vaccines as evaluated by the study doctor
    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
    25796337
    Citation
    Wiedmann RT, Reisinger KS, Hartzel J, Malacaman E, Senders SD, Giacoletti KE, Shaw E, Kuter BJ, Schodel F, Musey LK. M-M-R((R))II manufactured using recombinant human albumin (rHA) and M-M-R((R))II manufactured using human serum albumin (HSA) exhibit similar safety and immunogenicity profiles when administered as a 2-dose regimen to healthy children. Vaccine. 2015 Apr 27;33(18):2132-40. doi: 10.1016/j.vaccine.2015.03.017. Epub 2015 Mar 18.
    Results Reference
    background
    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

    Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

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