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Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(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: 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 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

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 Lot 1

    ProQuad Lot 2

    ProQuad Lot 3

    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
    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 Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline
    Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 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
    Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Varicella
    Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Measles.
    Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Mumps.
    Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
    Postvaccination observed Geometric Mean Titer of antibody to Rubella
    Number of Participants With Serious Vaccine-related CAEs
    Subjects 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).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2009
    Last Updated
    November 20, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00985153
    Brief Title
    Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
    Official Title
    Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2000 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    May 2001 (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 three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

    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
    3927 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    ProQuad Lot 1
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    ProQuad Lot 2
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    ProQuad Lot 3
    Arm Title
    4
    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 at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Varivax
    Intervention Description
    A Single 0.5 mL subcutaneous injection at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: M-M-R II
    Intervention Description
    A Single 0.5 mL subcutaneous injection 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
    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 Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
    Description
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
    Description
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 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
    Title
    Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - 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 Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - 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 Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - 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 Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
    Description
    Postvaccination observed Geometric Mean Titer of antibody to Rubella
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Serious Vaccine-related CAEs
    Description
    Subjects 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

    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
    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
    16804432
    Citation
    Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.
    Results Reference
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    Learn more about this trial

    Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

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