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ProQuad Dose Selection Study (V221-011)(COMPLETED)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Comparator: M-M-R II
Comparator: PUVV
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 measles, mumps, rubella, varicella, and zoster

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 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    ProQuad (low dose)

    ProQuad (middle dose)

    ProQuad (high dose)

    M-M-R II + PUVV

    Outcomes

    Primary Outcome Measures

    Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
    Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units

    Secondary Outcome Measures

    Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
    Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline
    Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
    Antibody response to Mumps at 6 weeks postvaccination in participants 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 in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline
    Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
    Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
    Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
    Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
    Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
    Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
    Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
    Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
    Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
    Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)

    Full Information

    First Posted
    September 25, 2009
    Last Updated
    March 23, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00986232
    Brief Title
    ProQuad Dose Selection Study (V221-011)(COMPLETED)
    Official Title
    A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1999 (undefined)
    Primary Completion Date
    April 2000 (Actual)
    Study Completion Date
    September 2000 (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
    A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

    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
    1551 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    ProQuad (low dose)
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    ProQuad (middle dose)
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    ProQuad (high dose)
    Arm Title
    4
    Arm Type
    Active Comparator
    Arm Description
    M-M-R II + PUVV
    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 ProQuad (low, middle, or high dose) at Day 0 and Day 90
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: M-M-R II
    Intervention Description
    A single 0.5 mL subcutaneous injection at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: PUVV
    Intervention Description
    A single 0.5 mL subcutaneous injection at Day 0
    Primary Outcome Measure Information:
    Title
    Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
    Description
    Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units
    Time Frame
    6 weeks postvaccination
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
    Description
    Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles 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 in participants 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 in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
    Description
    Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
    Time Frame
    6 weeks Postvaccination Visit 1 or Visit 2
    Title
    Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
    Description
    Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
    Description
    Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
    Description
    Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
    Description
    Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)
    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 measles, mumps, rubella, varicella, and zoster 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
    16094218
    Citation
    Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9. Erratum In: Pediatr Infect Dis J. 2005 Nov;24(11):983.
    Results Reference
    result

    Learn more about this trial

    ProQuad Dose Selection Study (V221-011)(COMPLETED)

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