Back to resultsSafety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)
Primary Purpose
Shingles
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
zoster vaccine live (Oka/Merck)
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional prevention trial for Shingles
Eligibility Criteria
Inclusion Criteria: Individuals who are at least 60 years of age with a history of varicella (shingles) Females must have been postmenopausal. Exclusion Criteria: Subjects who did not previously participate in the main study of this protocol. Subject had shingles since their 6 month follow-up visit in main phase of study.
Sites / Locations
Outcomes
Primary Outcome Measures
VZV ELISPOT response ~6 weeks after 1 and 2 doses
Secondary Outcome Measures
To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00109122
Brief Title
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)
Official Title
A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
July 2006 (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 the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).
Detailed Description
The duration of treatment is 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
zoster vaccine live (Oka/Merck)
Other Intervention Name(s)
V211
Intervention Type
Biological
Intervention Name(s)
Comparator: placebo (unspecified)
Primary Outcome Measure Information:
Title
VZV ELISPOT response ~6 weeks after 1 and 2 doses
Time Frame
6 weeks after 1 and 2 doses
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo
Time Frame
1 through 3 years after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals who are at least 60 years of age with a history of varicella (shingles)
Females must have been postmenopausal.
Exclusion Criteria:
Subjects who did not previously participate in the main study of this protocol.
Subject had shingles since their 6 month follow-up visit in main phase of study.
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
22154769
Citation
Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, Levin MJ, Freeman C, Chalikonda I, Li J, Smith JG, Caulfield MJ, Stek JE, Chan IS, Vessey R, Schodel FP, Annunziato PW, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >/=60 years of age. Vaccine. 2012 Jan 20;30(5):904-10. doi: 10.1016/j.vaccine.2011.11.096. Epub 2011 Dec 7.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsiis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)
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