A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
2 other identifiers
interventional
101
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2006
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 2, 2006
CompletedFirst Posted
Study publicly available on registry
May 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedResults Posted
Study results publicly available
December 15, 2010
CompletedJanuary 26, 2015
January 1, 2015
1.2 years
May 2, 2006
May 12, 2010
January 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
To Day 28 postvaccination
Secondary Outcomes (2)
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
From prevaccination (baseline) to 4 weeks postvaccination
Study Arms (2)
ZOSTAVAX™ / Placebo
EXPERIMENTALZoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
Placebo / ZOSTAVAX™
EXPERIMENTALPlacebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
Interventions
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
1 dose 0.65 mL/dose subcutaneous injection of placebo.
Eligibility Criteria
You may qualify if:
- Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 20416263RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2006
First Posted
May 5, 2006
Study Start
May 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
January 26, 2015
Results First Posted
December 15, 2010
Record last verified: 2015-01