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Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

Primary Purpose

Varicella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is in good health based on medical history
  • Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Exclusion Criteria:

  • Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
  • Subject has history of immune disorders
  • Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
  • Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
  • Subject has received a live vaccine within 30 days of first dose of study vaccine
  • Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
  • Subject has had a fever within 72 hours of study start

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VARIVAX 2007 process + M-M-R II

    VARIVAX 1999 process + M-M-R II

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
    Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 9, 2009
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00822237
    Brief Title
    Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
    Official Title
    Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    December 2009 (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 test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.
    Detailed Description
    This treatment has been approved for sale to the public.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicella

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    598 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VARIVAX 2007 process + M-M-R II
    Arm Type
    Experimental
    Arm Title
    VARIVAX 1999 process + M-M-R II
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
    Intervention Description
    VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
    Intervention Description
    VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
    Intervention Type
    Biological
    Intervention Name(s)
    Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
    Intervention Description
    M-M-R II in two 0.5 mL doses by injection ~6 weeks apart
    Primary Outcome Measure Information:
    Title
    Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
    Description
    Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.
    Time Frame
    6 weeks following first vaccination

    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 based on medical history Subject has no history of measles, mumps, rubella, chickenpox, or shingles Exclusion Criteria: Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination Subject has history of immune disorders Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start Subject has received an inactivated vaccine within 14 days of first dose of study vaccine Subject has received a live vaccine within 30 days of first dose of study vaccine Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine Subject has had a fever within 72 hours of study start
    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

    Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

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