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Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

Primary Purpose

Shingles

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 Shingles

Eligibility Criteria

50 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be between 50 - 59 years of age
  • No fever on day of vaccination
  • Females of reproductive potential must be willing to use acceptable form of birth control

Exclusion Criteria:

  • Have received chicken pox or shingles vaccine
  • Have already had shingles
  • Have recently had another vaccination
  • Pregnant or breast feeding. Have participated in another research study in the last 30 days
  • You are taking certain antiviral drugs
  • History of allergic reaction to any vaccine component, including gelatin or neomycin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Zostavax™

    Placebo

    Arm Description

    Participants randomized to receive Zoster Vaccine, Live (Zostavax™).

    Participants randomized to receive Placebo.

    Outcomes

    Primary Outcome Measures

    Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
    Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.

    Secondary Outcome Measures

    Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group
    VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.
    Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period
    A serious adverse event is defined as 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
    September 21, 2007
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00534248
    Brief Title
    Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
    Official Title
    A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (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
    This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    22439 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zostavax™
    Arm Type
    Experimental
    Arm Description
    Participants randomized to receive Zoster Vaccine, Live (Zostavax™).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants randomized to receive Placebo.
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine, Live (Zostavax™)
    Other Intervention Name(s)
    V211, Zostavax™
    Intervention Description
    A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.
    Primary Outcome Measure Information:
    Title
    Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
    Description
    Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.
    Time Frame
    2 Years
    Secondary Outcome Measure Information:
    Title
    Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group
    Description
    VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.
    Time Frame
    6 Weeks
    Title
    Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period
    Description
    A serious adverse event is defined as 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
    Through 42 days post-vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be between 50 - 59 years of age No fever on day of vaccination Females of reproductive potential must be willing to use acceptable form of birth control Exclusion Criteria: Have received chicken pox or shingles vaccine Have already had shingles Have recently had another vaccination Pregnant or breast feeding. Have participated in another research study in the last 30 days You are taking certain antiviral drugs History of allergic reaction to any vaccine component, including gelatin or neomycin
    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
    24823623
    Citation
    Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13.
    Results Reference
    derived
    PubMed Identifier
    23908486
    Citation
    Levin MJ, Schmader KE, Gnann JW, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Varicella-zoster virus-specific antibody responses in 50-59-year-old recipients of zoster vaccine. J Infect Dis. 2013 Nov 1;208(9):1386-90. doi: 10.1093/infdis/jit342. Epub 2013 Aug 1.
    Results Reference
    derived
    PubMed Identifier
    22291101
    Citation
    Schmader KE, Levin MJ, Gnann JW Jr, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis. 2012 Apr;54(7):922-8. doi: 10.1093/cid/cir970. Epub 2012 Jan 30.
    Results Reference
    derived

    Learn more about this trial

    Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

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