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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

March 7, 2007
November 4, 2009
March 2006
May 2007   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00444860 on ClinicalTrials.gov Archive Site
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ZOSTAVAX(R) Local Registration Trial
A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan

The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Varicella Virus Infection
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
Experimental: 1
Zostavax
Intervention: Biological: Zoster Vaccine, Live, (Oka-Merck)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00444860
2007_008, MKV211-019
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP