ZOSTAVAX(R) Local Registration Trial - Full Text View

Purpose

The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.

Condition	Intervention	Phase
Varicella Virus Infection	Biological: Zoster Vaccine, Live, (Oka-Merck)	Phase III

MedlinePlus related topics:

Chickenpox Shingles

Drug Information available for:

Zostavax

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan

Further study details as provided by Merck:

Primary Outcome Measures:

The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed. [ Time Frame: prevaccination and 4 weeks postvaccination ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	February 2007
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Zostavax	Biological: Zoster Vaccine, Live, (Oka-Merck) A single dose of 0.65 ml of Zostavax injection was given to each study subject

Eligibility

Criteria

Inclusion Criteria:

Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
- Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
- Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
Subject Must Sign Informed Consent Prior To Any Study Procedure
Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
Any Underlying Chronic Illness Must Be In Stable Condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444860

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_008, MKV211-019
First Received:	March 7, 2007
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00444860
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Virus Diseases

Herpes Zoster

Chickenpox

DNA Virus Infections

Chicken pox

Healthy

Herpesviridae Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00444860