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

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

This study has been completed.

First Received: August 11, 2005 Last Updated: February 5, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00130793

Purpose

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.

Condition	Intervention	Phase
Herpes Zoster	Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation	Phase III

MedlinePlus related topics: Chickenpox Shingles

Drug Information available for: Zostavax

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

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

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 ]

Enrollment:	368
Study Start Date:	August 2005
Study Completion Date:	January 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental zoster vaccine live (Oka/Merck) refrigerated formulation	Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation 1 dose of 0.65mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
2: Active Comparator zoster vaccine live (Oka/Merck) frozen formulation	Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation 1 dose of 0.65mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1

Detailed Description:

The duration of treatment is 4 weeks.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130793

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_035, V211-010
Study First Received:	August 11, 2005
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00130793 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Chickenpox
DNA Virus Infections
Herpesviridae Infections

Additional relevant MeSH terms:

Virus Diseases
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009