A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
zoster vaccine live (ZOSTAVAX™)
Comparator: Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster
Eligibility Criteria
Inclusion Criteria: Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment Exclusion Criteria: History of allergy to any vaccine component Prior receipt of a varicella or zoster vaccine Ability to defend against infection is suppressed by a medical condition or medication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ZOSTAVAX™ / Placebo
Placebo / ZOSTAVAX™
Arm Description
Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
Outcomes
Primary Outcome Measures
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Secondary Outcome Measures
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00322231
Brief Title
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
Official Title
A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (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
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZOSTAVAX™ / Placebo
Arm Type
Experimental
Arm Description
Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
Arm Title
Placebo / ZOSTAVAX™
Arm Type
Experimental
Arm Description
Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
Intervention Type
Biological
Intervention Name(s)
zoster vaccine live (ZOSTAVAX™)
Other Intervention Name(s)
Zostavax
Intervention Description
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo
Intervention Description
1 dose 0.65 mL/dose subcutaneous injection of placebo.
Primary Outcome Measure Information:
Title
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Description
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Time Frame
To Day 28 postvaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Description
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Time Frame
4 weeks postvaccination
Title
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
Description
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Time Frame
From prevaccination (baseline) to 4 weeks postvaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
Exclusion Criteria:
History of allergy to any vaccine component
Prior receipt of a varicella or zoster vaccine
Ability to defend against infection is suppressed by a medical condition or medication
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
Citations:
PubMed Identifier
20416263
Citation
Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
Results Reference
result
Learn more about this trial
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
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