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A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
Comparator: M-M-R II
Comparator: Varivax
Comparator: Placebo
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

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In good health
  • Received primary dose of M-M-R II at less than or equal to 12 months of age
  • Received primary dose of Varivax at less than or equal to 12 months of age
  • Negative history of varicella, zoster, measles, mumps, and rubella

Exclusion Criteria:

  • history of receiving more than once dose of M-M-R II or Varivax
  • Any immune impairment or deficiency
  • Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
  • Vaccination with an inactive vaccine with in the past 14 days
  • Vaccination with a live vaccine within the past 30 days
  • Receipt of immune globulin, or blood product in the past 5 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    ProQuad + Placebo

    M-M-R II + Placebo

    M-M-R II + Varivax

    Outcomes

    Primary Outcome Measures

    Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Varicella
    Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Measles
    Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Mumps
    Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Rubella

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2009
    Last Updated
    July 16, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00985166
    Brief Title
    A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
    Official Title
    Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    May 2002 (Actual)
    Study Completion Date
    May 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with 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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    801 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    ProQuad + Placebo
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    M-M-R II + Placebo
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    M-M-R II + Varivax
    Intervention Type
    Biological
    Intervention Name(s)
    ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
    Other Intervention Name(s)
    ProQuad
    Intervention Description
    A Single 0.5 mL subcutaneous injection at Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: M-M-R II
    Intervention Description
    A Single 0.5 mL subcutaneous injection at Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Varivax
    Intervention Description
    A Single 0.5 mL subcutaneous injection at Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    A Single 0.5 mL subcutaneous placebo injection at Day 1
    Primary Outcome Measure Information:
    Title
    Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Description
    Postvaccination observed Geometric Mean Titer of antibody to Varicella
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Description
    Postvaccination observed Geometric Mean Titer of antibody to Measles
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Description
    Postvaccination observed Geometric Mean Titer of antibody to Mumps
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
    Description
    Postvaccination observed Geometric Mean Titer of antibody to Rubella
    Time Frame
    6 weeks Postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In good health Received primary dose of M-M-R II at less than or equal to 12 months of age Received primary dose of Varivax at less than or equal to 12 months of age Negative history of varicella, zoster, measles, mumps, and rubella Exclusion Criteria: history of receiving more than once dose of M-M-R II or Varivax Any immune impairment or deficiency Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination Vaccination with an inactive vaccine with in the past 14 days Vaccination with a live vaccine within the past 30 days Receipt of immune globulin, or blood product in the past 5 months
    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
    16452343
    Citation
    Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092. Erratum In: Pediatrics. 2006 Jun;117(6):2338.
    Results Reference
    result

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    A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

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