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A Study of ProQuad™ in Healthy Children in Korea (V221-023)

Primary Purpose

Measles, Mumps, Rubella

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
M-M-R™ II and Varivax™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles focused on measuring Measles, Mumps, Rubella, Varicella

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is in good health
  • Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria:

  • Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
  • Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
  • Subject has a history of seizure disorder
  • Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
  • Subject has received an inactivated vaccine within the past 14 days
  • Subject has received a live vaccine within the past 30 days
  • Subject has received immune globulin within the past 5 months
  • Subject has a recent history of fever (within the last 72 hours)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ProQuad™

    M-M-R™ II and Varivax™

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
    Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
    Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
    Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
    Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
    Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
    Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline

    Secondary Outcome Measures

    Geometric Mean Titer of Measles Antibodies
    Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
    Geometric Mean Titer of Mumps Antibodies
    Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
    Geometric Mean Titer of Rubella Antibodies
    Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
    Geometric Mean Titer of VZV (gpELISA) Antibodies
    Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline

    Full Information

    First Posted
    February 6, 2009
    Last Updated
    March 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00839917
    Brief Title
    A Study of ProQuad™ in Healthy Children in Korea (V221-023)
    Official Title
    A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Measles, Mumps, Rubella, Varicella
    Keywords
    Measles, Mumps, Rubella, Varicella

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ProQuad™
    Arm Type
    Experimental
    Arm Title
    M-M-R™ II and Varivax™
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
    Other Intervention Name(s)
    V221
    Intervention Description
    Single administration of 0.5 mL subcutaneous injection
    Intervention Type
    Biological
    Intervention Name(s)
    M-M-R™ II and Varivax™
    Intervention Description
    Single administration of 0.5 mL subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
    Description
    Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
    Time Frame
    6 weeks postvaccination
    Title
    Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
    Description
    Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
    Time Frame
    6 weeks postvaccination
    Title
    Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
    Description
    Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
    Time Frame
    6 weeks postvaccination
    Title
    Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    Description
    Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline
    Time Frame
    6 weeks postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Titer of Measles Antibodies
    Description
    Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
    Time Frame
    6 weeks postvaccination
    Title
    Geometric Mean Titer of Mumps Antibodies
    Description
    Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
    Time Frame
    6 weeks postvaccination
    Title
    Geometric Mean Titer of Rubella Antibodies
    Description
    Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
    Time Frame
    6 weeks postvaccination
    Title
    Geometric Mean Titer of VZV (gpELISA) Antibodies
    Description
    Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline
    Time Frame
    6 weeks postvaccination
    Other Pre-specified Outcome Measures:
    Title
    Percentage of Participants With Measles-like Rash
    Time Frame
    Through 6 weeks postvaccination
    Title
    Percentage of Participants With Varicella-like Rash
    Time Frame
    Through 6 weeks postvaccination
    Title
    Percentage of Participants With Rubella-like Rash
    Time Frame
    Through 6 weeks postvaccination
    Title
    Percentage of Participants With Zoster-like Rash
    Time Frame
    Through 6 weeks postvaccination
    Title
    Percentage of Participants With Any Systemic Adverse Experience
    Description
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences.
    Time Frame
    Through 6 weeks postvaccination
    Title
    Percentage of Participants With Injection-site Adverse Experiences
    Description
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.
    Time Frame
    Through 6 weeks postvaccination
    Title
    Percentage of Participants With Injection-site Adverse Experiences
    Description
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.
    Time Frame
    Through 5 days postvaccination
    Title
    Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)
    Time Frame
    Through 6 weeks postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    23 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is in good health Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster Exclusion Criteria: Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity Subject has a history of seizure disorder Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks Subject has received an inactivated vaccine within the past 14 days Subject has received a live vaccine within the past 30 days Subject has received immune globulin within the past 5 months Subject has a recent history of fever (within the last 72 hours)
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    A Study of ProQuad™ in Healthy Children in Korea (V221-023)

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