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A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
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, rubella or varicella History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control Group

    Mumps Expiry Group 1

    Mumps Expiry Group 2

    Arm Description

    M-M-R(TM) II at current release potency

    M-M-R(TM) II at intermediate expiry potency

    M-M-R(TM) II at expiry potency

    Outcomes

    Primary Outcome Measures

    Neutralizing antibodies to mumps at 6 weeks postvaccination

    Secondary Outcome Measures

    Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination

    Full Information

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

    Unique Protocol Identification Number
    NCT00092391
    Brief Title
    A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
    Official Title
    A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1999 (undefined)
    Primary Completion Date
    July 2001 (Actual)
    Study Completion Date
    July 2001 (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 determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.

    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 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1997 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    M-M-R(TM) II at current release potency
    Arm Title
    Mumps Expiry Group 1
    Arm Type
    Experimental
    Arm Description
    M-M-R(TM) II at intermediate expiry potency
    Arm Title
    Mumps Expiry Group 2
    Arm Type
    Experimental
    Arm Description
    M-M-R(TM) II at expiry potency
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
    Intervention Description
    0.5 mL subcutaneous injection of one of three sub-lots on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
    Intervention Description
    0.5 mL subcutaneous injection on Day 0
    Primary Outcome Measure Information:
    Title
    Neutralizing antibodies to mumps at 6 weeks postvaccination
    Time Frame
    6 weeks postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination
    Time Frame
    6 weeks and 1 year 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, rubella or varicella History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin
    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

    A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)

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