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ZOSTAVAX(R) Local Registration Trial (V211-019)

Primary Purpose

Varicella Virus Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zoster Vaccine, Live, (Oka-Merck)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella Virus Infection

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent

  • All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test

    • Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea

  • A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination

    • Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
  • Subject Must Sign Informed Consent Prior To Any Study Procedure
  • Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
  • Any Underlying Chronic Illness Must Be In Stable Condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Zostavax

    Outcomes

    Primary Outcome Measures

    The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2007
    Last Updated
    June 3, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00444860
    Brief Title
    ZOSTAVAX(R) Local Registration Trial (V211-019)
    Official Title
    A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (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 obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Zostavax
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine, Live, (Oka-Merck)
    Other Intervention Name(s)
    Zostavax
    Intervention Description
    A single dose of 0.65 ml of Zostavax injection was given to each study subject
    Primary Outcome Measure Information:
    Title
    The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
    Time Frame
    prevaccination and 4 weeks postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy Subject Must Sign Informed Consent Prior To Any Study Procedure Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination Any Underlying Chronic Illness Must Be In Stable Condition
    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
    25681662
    Citation
    Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11.
    Results Reference
    result

    Learn more about this trial

    ZOSTAVAX(R) Local Registration Trial (V211-019)

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