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Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ZOSTAVAX
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 aged >=50 years
  • Varicella history-positive or residence for >30 years in a country with endemic VZV infection

Exclusion Criteria:

  • Febrile illness
  • History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
  • Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
  • Prior receipt of varicella or zoster vaccine
  • Active untreated tuberculosis
  • Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
  • Receipt of medication / vaccine that may interfere with study assessments
  • Known or suspected immune dysfunction
  • User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
  • Any condition that might interfere with the interpretation of the study,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ZOSTAVAX intramuscular (IM) route

    ZOSTAVAX subcutaneous (SC) route

    Arm Description

    Single dose of 0.65 mL via IM injection

    Single dose of 0.65 mL via SC injection

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination
    Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route
    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

    Secondary Outcome Measures

    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route
    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination
    Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies
    Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)
    Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies
    Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.
    Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction
    Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.
    Percentage of Participants Who Report at Least 1 Systemic Adverse Event
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.
    Percentage of Participants Who Report at Least 1 Serious Adverse Event
    A serious adverse event (SAE) 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. The percentage of participants who reported an SAE within 35 days of vaccination were recorded.

    Full Information

    First Posted
    July 7, 2011
    Last Updated
    December 20, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01391546
    Brief Title
    Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)
    Official Title
    An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 20, 2011 (Actual)
    Primary Completion Date
    October 15, 2012 (Actual)
    Study Completion Date
    October 15, 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    PRIMARY OBJECTIVES Two co-primary objectives are: To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC) To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination SECONDARY OBJECTIVES Immunogenicity objectives To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route Safety objective - To describe the safety profile of ZOSTAVAX administered by IM or SC route

    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
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    354 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ZOSTAVAX intramuscular (IM) route
    Arm Type
    Experimental
    Arm Description
    Single dose of 0.65 mL via IM injection
    Arm Title
    ZOSTAVAX subcutaneous (SC) route
    Arm Type
    Active Comparator
    Arm Description
    Single dose of 0.65 mL via SC injection
    Intervention Type
    Biological
    Intervention Name(s)
    ZOSTAVAX
    Other Intervention Name(s)
    V211
    Intervention Description
    1 dose 0.65 mL
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination
    Description
    Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
    Time Frame
    4 week post-vaccination
    Title
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route
    Description
    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
    Time Frame
    Pre-vaccination (Day 0) and 4 week post-vaccination
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route
    Description
    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination
    Time Frame
    Pre-vaccination (Day 0) and 4 week post-vaccination
    Title
    Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies
    Description
    Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)
    Time Frame
    4 week post-vaccination
    Title
    Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies
    Description
    Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.
    Time Frame
    Pre-vaccination (Day 0) and 4 week post-vaccination
    Title
    Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction
    Description
    Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.
    Time Frame
    up to 28 days after vaccination
    Title
    Percentage of Participants Who Report at Least 1 Systemic Adverse Event
    Description
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.
    Time Frame
    up to Day 28 after vaccination
    Title
    Percentage of Participants Who Report at Least 1 Serious Adverse Event
    Description
    A serious adverse event (SAE) 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. The percentage of participants who reported an SAE within 35 days of vaccination were recorded.
    Time Frame
    up to 35 days after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults aged >=50 years Varicella history-positive or residence for >30 years in a country with endemic VZV infection Exclusion Criteria: Febrile illness History of hypersensitivity or anaphylactoid reaction to any of the vaccine components Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination Prior receipt of varicella or zoster vaccine Active untreated tuberculosis Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection Receipt of medication / vaccine that may interfere with study assessments Known or suspected immune dysfunction User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year Any condition that might interfere with the interpretation of the study,
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    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://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25555381
    Citation
    Diez-Domingo J, Weinke T, Garcia de Lomas J, Meyer CU, Bertrand I, Eymin C, Thomas S, Sadorge C. Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged >/=50 years: a randomised non-inferiority clinical trial. Vaccine. 2015 Feb 4;33(6):789-95. doi: 10.1016/j.vaccine.2014.12.024. Epub 2014 Dec 30.
    Results Reference
    result

    Learn more about this trial

    Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

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