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ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zoster Vaccine, Live
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

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

Inclusion Criteria:

  • 60+ years of Age
  • Signed an informed consent prior to the start of study
  • Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
  • Females must be postmenopausal or have a negative pregnancy test

Exclusion Criteria:

  • A history of allergic reaction to any vaccine component (including gelatin or neomycin)
  • Prior receipt of any varicella or zoster vaccine
  • Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
  • Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
  • Subject is pregnant or breastfeeding
  • Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination
  • An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
  • Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
  • Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
  • Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Arm 1: vaccine

    Arm 2: Placebo Comparator

    Outcomes

    Primary Outcome Measures

    Serious Adverse Events Reported Within 42 Days Postvaccination
    Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

    Secondary Outcome Measures

    Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
    Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

    Full Information

    First Posted
    October 29, 2007
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00550745
    Brief Title
    ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
    Official Title
    A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (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 the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    11999 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Arm 1: vaccine
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Arm 2: Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine, Live
    Intervention Description
    single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    single 0.65 mL Placebo injection. 6 month treatment period.
    Primary Outcome Measure Information:
    Title
    Serious Adverse Events Reported Within 42 Days Postvaccination
    Description
    Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
    Time Frame
    42 Days
    Secondary Outcome Measure Information:
    Title
    Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
    Description
    Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 60+ years of Age Signed an informed consent prior to the start of study Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination Females must be postmenopausal or have a negative pregnancy test Exclusion Criteria: A history of allergic reaction to any vaccine component (including gelatin or neomycin) Prior receipt of any varicella or zoster vaccine Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination Subject is pregnant or breastfeeding Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir
    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
    Citations:
    PubMed Identifier
    22048110
    Citation
    Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, Wang WW, Chan IS, Annunziato PW, Parrino J. Safety and tolerability of zoster vaccine in adults >/=60 years old. Hum Vaccin. 2011 Nov;7(11):1130-6. doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.
    Results Reference
    result

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    ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

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