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Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

Primary Purpose

Herpes Zoster, Shingles

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zoster Vaccine Live
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:

  • No fever on day of vaccination
  • Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
  • Underlying chronic illnesses must be stable

Exclusion Criteria:

  • History of hypersensitivity reaction to any vaccine component
  • Prior receipt of a varicella or zoster vaccine
  • Prior history of herpes zoster
  • Have recently had another vaccination
  • Have recently received blood products other than autologous blood transfusion
  • Pregnant or breast feeding
  • Use of immunosuppressive therapy
  • Known or suspected immune dysfunction
  • Use of nontopical antiviral therapy with activity against herpesvirus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Zoster Vaccine Live

    Arm Description

    Outcomes

    Primary Outcome Measures

    The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
    Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
    GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
    Number of Participants With Serious Adverse Events
    A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2012
    Last Updated
    August 19, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01527370
    Brief Title
    Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
    Official Title
    A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 31, 2012 (Actual)
    Primary Completion Date
    April 9, 2013 (Actual)
    Study Completion Date
    April 9, 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zoster Vaccine Live
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine Live
    Other Intervention Name(s)
    ZOSTAVAX™, V211
    Intervention Description
    One approximately 0.65 mL injection subcutaneously on Day 1
    Primary Outcome Measure Information:
    Title
    The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
    Description
    Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
    Time Frame
    Prevaccination up to 6 weeks postvaccination
    Title
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
    Description
    GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
    Time Frame
    Prevaccination up to 6 weeks postvaccination
    Title
    Number of Participants With Serious Adverse Events
    Description
    A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
    Time Frame
    Up to 42 days postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: No fever on day of vaccination Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal Underlying chronic illnesses must be stable Exclusion Criteria: History of hypersensitivity reaction to any vaccine component Prior receipt of a varicella or zoster vaccine Prior history of herpes zoster Have recently had another vaccination Have recently received blood products other than autologous blood transfusion Pregnant or breast feeding Use of immunosuppressive therapy Known or suspected immune dysfunction Use of nontopical antiviral therapy with activity against herpesvirus

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    31325263
    Citation
    Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX) in Healthy Adults in India. J Assoc Physicians India. 2018 Jul;66(7):50-54.
    Results Reference
    result

    Learn more about this trial

    Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

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