A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
January 14, 2015 updated by: Merck Sharp & Dohme LLC
A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)
The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
Study Overview
Status
Completed
Conditions
Detailed Description
The duration of treatment is 4 weeks.
Study Type
Interventional
Enrollment (Actual)
368
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)
Exclusion Criteria:
- Prior history of herpes zoster (shingles)
- Prior receipt of varicella or zoster vaccine
- Immunosuppressed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: zoster vaccine live (Oka/Merck) refrigerated formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
|
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
|
|
Active Comparator: zoster vaccine live (Oka/Merck) frozen formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
|
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Time Frame: 4 weeks
|
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Time Frame: 4 weeks
|
Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
Time Frame: From prevaccination (baseline) to 4 weeks postvaccination
|
GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination
|
From prevaccination (baseline) to 4 weeks postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
August 11, 2005
First Submitted That Met QC Criteria
August 12, 2005
First Posted (Estimate)
August 16, 2005
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 14, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V211-010
- 2005_035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.