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Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

Primary Purpose

Herpes Zoster, Shingles

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zoster Vaccine, Live (AMP)
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
  • History of varicella or residence in a VZV-endemic area for ≥30 years
  • Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria:

  • History of hypersensitivity reaction to any vaccine component
  • Prior receipt of any varicella or zoster vaccine
  • Prior history of herpes zoster
  • Have recently had another vaccination
  • Pregnant or breastfeeding
  • Use of immunosuppressive therapy
  • Known or suspected immune dysfunction
  • Concomitant antiviral therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ZOSTAVAX™ (AMP)

    ZOSTAVAX™

    Arm Description

    ZOSTAVAX™ manufactured with an alternative process

    ZOSTAVAX™ manufactured with the current process

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
    VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).

    Secondary Outcome Measures

    Number of Participants With One or More Adverse Experiences (AEs)
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
    Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
    An SAE 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
    Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
    An SAE 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
    January 4, 2012
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01505647
    Brief Title
    Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
    Official Title
    A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    November 2012 (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 whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

    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
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    498 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ZOSTAVAX™ (AMP)
    Arm Type
    Experimental
    Arm Description
    ZOSTAVAX™ manufactured with an alternative process
    Arm Title
    ZOSTAVAX™
    Arm Type
    Active Comparator
    Arm Description
    ZOSTAVAX™ manufactured with the current process
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine, Live (AMP)
    Intervention Description
    One approximately 0.65-mL injection subcutaneously on Day 1
    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
    Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
    Description
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
    Time Frame
    Day 1 and Week 6 postvaccination
    Title
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
    Description
    VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
    Time Frame
    Day 1 (Baseline) to Week 6 postvaccination
    Secondary Outcome Measure Information:
    Title
    Number of Participants With One or More Adverse Experiences (AEs)
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
    Time Frame
    Day 1 to Day 42 postvaccination
    Title
    Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
    Description
    An SAE 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
    Day 1 to Day 42 postvaccination
    Title
    Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
    Description
    An SAE 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
    Day 1 to Day 182 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 History of varicella or residence in a VZV-endemic area for ≥30 years Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control Exclusion Criteria: History of hypersensitivity reaction to any vaccine component Prior receipt of any varicella or zoster vaccine Prior history of herpes zoster Have recently had another vaccination Pregnant or breastfeeding Use of immunosuppressive therapy Known or suspected immune dysfunction Concomitant antiviral therapy

    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

    Learn more about this trial

    Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

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