A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chicken Pox) . - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 11, 2005

Last Updated Date

February 5, 2009

Start Date ^†

August 2005

Current Primary Outcome Measures ^†

Change in VZV gpELISA antibody titer from prevaccination to 4 weeks postvaccination [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00130793 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Safety and tolerability as determined by vaccine-related serious adverse experiences for 28 days postvaccination [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chicken Pox)

Official Title ^†

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Bio-equivalence Study

Condition ^†

Herpes Zoster

Intervention ^†

Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation

Study Arms / Comparison Groups

Experimental: zoster vaccine live (Oka/Merck) refrigerated formulation
Active 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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

368

Completion Date

January 2006

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00130793

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

V211-010

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.