search
Back to results

A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
zoster vaccine live (ZOSTAVAX™)
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster

Eligibility Criteria

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

Inclusion Criteria: Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment Exclusion Criteria: History of allergy to any vaccine component Prior receipt of a varicella or zoster vaccine Ability to defend against infection is suppressed by a medical condition or medication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ZOSTAVAX™ / Placebo

    Placebo / ZOSTAVAX™

    Arm Description

    Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)

    Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)

    Outcomes

    Primary Outcome Measures

    Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
    SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event

    Secondary Outcome Measures

    Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
    The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
    GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination

    Full Information

    First Posted
    May 2, 2006
    Last Updated
    January 14, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00322231
    Brief Title
    A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
    Official Title
    A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 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 determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ZOSTAVAX™ / Placebo
    Arm Type
    Experimental
    Arm Description
    Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
    Arm Title
    Placebo / ZOSTAVAX™
    Arm Type
    Experimental
    Arm Description
    Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
    Intervention Type
    Biological
    Intervention Name(s)
    zoster vaccine live (ZOSTAVAX™)
    Other Intervention Name(s)
    Zostavax
    Intervention Description
    1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    1 dose 0.65 mL/dose subcutaneous injection of placebo.
    Primary Outcome Measure Information:
    Title
    Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
    Description
    SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
    Time Frame
    To Day 28 postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
    Description
    The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
    Time Frame
    4 weeks postvaccination
    Title
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
    Description
    GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
    Time Frame
    From prevaccination (baseline) to 4 weeks postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment Exclusion Criteria: History of allergy to any vaccine component Prior receipt of a varicella or zoster vaccine Ability to defend against infection is suppressed by a medical condition or medication
    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
    20416263
    Citation
    Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
    Results Reference
    result

    Learn more about this trial

    A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

    We'll reach out to this number within 24 hrs