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ZOSTAVAX(R) Local Registration Trial

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00444860
First received: March 7, 2007
Last updated: November 4, 2009
Last verified: November 2009
History of Changes
  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:

MedlinePlus related topics: Chickenpox Shingles
U.S. FDA Resources

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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 May 23, 2013