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Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
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: Healthy children 12-23 months of age Exclusion Criteria: Previously had measles, mumps, rubella, or varicella Compromised immune system

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percent of patients demonstrating adequate antibody titers 6 weeks following administration

    Secondary Outcome Measures

    Geometric mean titers (GMT) 6 weeks post vaccination

    Full Information

    First Posted
    September 22, 2004
    Last Updated
    November 13, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092430
    Brief Title
    Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
    Official Title
    A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 26, 2002 (Actual)
    Primary Completion Date
    June 9, 2003 (Actual)
    Study Completion Date
    June 9, 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.

    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
    1200 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks
    Primary Outcome Measure Information:
    Title
    Percent of patients demonstrating adequate antibody titers 6 weeks following administration
    Secondary Outcome Measure Information:
    Title
    Geometric mean titers (GMT) 6 weeks post 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: Healthy children 12-23 months of age Exclusion Criteria: Previously had measles, mumps, rubella, or varicella Compromised immune system
    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
    17502347
    Citation
    Bernstein HH, Eves K, Campbell K, Black SB, Twiggs JD, Reisinger KS, Conti RM, Flodmark CE, Rombo L, Klopfer S, Schodel F, Hartzel J, Kuter BJ; Refrigerator-Stable Formulation Study Group for ProQuad. Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live). Pediatrics. 2007 Jun;119(6):e1299-305. doi: 10.1542/peds.2006-2283. Epub 2007 May 14.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

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