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Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ZOSTAVAX™
Placebo to ZOSTAVAX™
Influenza Vaccine
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:

  • Has history of varicella or residence in a VZV-endemic area for ≥30 years
  • Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study

Exclusion Criteria:

  • Has history of hypersensitivity to any vaccine component
  • Has previously received any varicella or zoster vaccine
  • Has received an influenza vaccine for the 2015-16 season
  • Has history of Herpes zoster
  • Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
  • Is pregnant or breastfeeding, or expecting to conceive during the study
  • Has used immunosuppressant therapy
  • Has known or suspected immune dysfunction
  • Has experienced Guillain-Barré syndrome within 6 weeks
  • Has severe thrombocytopenia or any other coagulation disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Concomitant Vaccination

    Nonconcomitant Vaccination

    Arm Description

    ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4

    Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody
    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
    Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers
    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
    Geometric Mean Titers of H1N1-specific Influenza Virus Antibody
    Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Geometric Mean Titers of H3N2-specific Influenza Virus Antibody
    Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody
    Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody
    Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 7, 2015
    Last Updated
    October 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519855
    Brief Title
    Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
    Official Title
    A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 11, 2015 (Actual)
    Primary Completion Date
    January 26, 2016 (Actual)
    Study Completion Date
    January 26, 2016 (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
    The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.

    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
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    882 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Concomitant Vaccination
    Arm Type
    Experimental
    Arm Description
    ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
    Arm Title
    Nonconcomitant Vaccination
    Arm Type
    Experimental
    Arm Description
    Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
    Intervention Type
    Biological
    Intervention Name(s)
    ZOSTAVAX™
    Other Intervention Name(s)
    V211
    Intervention Description
    A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo to ZOSTAVAX™
    Intervention Description
    A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
    Intervention Type
    Biological
    Intervention Name(s)
    Influenza Vaccine
    Other Intervention Name(s)
    Fluzone, Vaxigrip
    Intervention Description
    A single open-label administration of 0.5 mL intramuscular injection on Day 1
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody
    Description
    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
    Time Frame
    Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
    Title
    Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers
    Description
    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
    Time Frame
    Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
    Title
    Geometric Mean Titers of H1N1-specific Influenza Virus Antibody
    Description
    Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Time Frame
    Baseline and 4 weeks after Influenza vaccination (Week 4)
    Title
    Geometric Mean Titers of H3N2-specific Influenza Virus Antibody
    Description
    Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Time Frame
    Baseline and 4 weeks after Influenza vaccination (Week 4)
    Title
    Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody
    Description
    Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Time Frame
    Baseline and 4 weeks after Influenza vaccination (Week 4)
    Title
    Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody
    Description
    Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
    Time Frame
    Baseline and 4 weeks after Influenza vaccination (Week 4)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Has history of varicella or residence in a VZV-endemic area for ≥30 years Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study Exclusion Criteria: Has history of hypersensitivity to any vaccine component Has previously received any varicella or zoster vaccine Has received an influenza vaccine for the 2015-16 season Has history of Herpes zoster Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination Is pregnant or breastfeeding, or expecting to conceive during the study Has used immunosuppressant therapy Has known or suspected immune dysfunction Has experienced Guillain-Barré syndrome within 6 weeks Has severe thrombocytopenia or any other coagulation disorder
    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
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    28830693
    Citation
    Levin MJ, Buchwald UK, Gardner J, Martin J, Stek JE, Brown E, Popmihajlov Z. Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. Vaccine. 2018 Jan 2;36(1):179-185. doi: 10.1016/j.vaccine.2017.08.029. Epub 2017 Aug 19.
    Results Reference
    result

    Learn more about this trial

    Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)

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