ZOSTAVAX(R) Local Registration Trial

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00444860
First received: March 7, 2007
Last updated: November 4, 2009
Last verified: November 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: March 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zostavax
Biological: Zoster Vaccine, Live, (Oka-Merck)
A single dose of 0.65 ml of Zostavax injection was given to each study subject
Other Name: Zostavax

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00444860     History of Changes
Other Study ID Numbers: 2007_008, MKV211-019
Study First Received: March 7, 2007
Last Updated: November 4, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Virus Diseases
Herpesviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 01, 2014