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ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Comparator: Placebo
Comparator: Varivax
Comparator: M-M-R II
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 - 23 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In good health
  • Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion Criteria:

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
  • 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
  • Immune globulin or any blood product administered in the past 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    ProQuad™ (V221) + Placebo Followed by ProQuad™

    M-M-R™ II + VARIVAX™

    Outcomes

    Primary Outcome Measures

    Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline

    Secondary Outcome Measures

    Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline
    Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
    Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline
    Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline

    Full Information

    First Posted
    September 10, 2009
    Last Updated
    October 5, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00975507
    Brief Title
    ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
    Official Title
    A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1998 (undefined)
    Primary Completion Date
    January 1999 (Actual)
    Study Completion Date
    June 1999 (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
    This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

    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
    480 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    ProQuad™ (V221) + Placebo Followed by ProQuad™
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    M-M-R™ II + VARIVAX™
    Intervention Type
    Biological
    Intervention Name(s)
    Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
    Other Intervention Name(s)
    ProQuad™
    Intervention Description
    a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    a single 0.5 mL subcutaneous placebo injection at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Varivax
    Intervention Description
    a single 0.5 mL subcutaneous injection of Varivax at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: M-M-R II
    Intervention Description
    a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
    Primary Outcome Measure Information:
    Title
    Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
    Description
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline
    Time Frame
    6 weeks Postvaccination
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
    Description
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
    Description
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
    Description
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
    Description
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
    Time Frame
    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: In good health Negative clinical history of varicella, shingles, measles, mumps, and rubella Exclusion Criteria: Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination 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 Immune globulin or any blood product administered in the past 3 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
    16094217
    Citation
    Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1.
    Results Reference
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    ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

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