A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

Tracking Information
First Submitted Date ICMJE	August 11, 2005
First Posted Date ICMJE	August 16, 2005
Results First Submitted Date	May 11, 2009
Results First Posted Date	July 3, 2009
Last Update Posted Date	January 26, 2015
Study Start Date ICMJE	August 2005
Actual Primary Completion Date	November 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 5, 2011)	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.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00130793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 5, 2011)	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
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE; (submitted: January 16, 2014)	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
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
Official Title ICMJE	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)
Brief Summary	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.
Detailed Description	The duration of treatment is 4 weeks.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Herpes Zoster
Intervention ICMJE	Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1; Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
Study Arms	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 Intervention: Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation; 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 Intervention: Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
Publications *	Gilderman LI, Lawless JF, Nolen TM, Sterling T, Rutledge RZ, Fernsler DA, Azrolan N, Sutradhar SC, Wang WW, Chan IS, Schlienger K, Schödel F, Silber JL; Zostavax Protocol 010 Study Group. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clin Vaccine Immunol. 2008 Feb;15(2):314-9. Epub 2007 Dec 12.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 5, 2009)	368
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	November 2005
Actual Primary Completion Date	November 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	50 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00130793
Other Study ID Numbers ICMJE	V211-010; 2005_035
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	January 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP