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ZOSTAVAX(R) Local Registration Trial (V211-019)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00444860
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Varicella Virus Infection Biological: Zoster Vaccine, Live, (Oka-Merck) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444860


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00444860     History of Changes
Other Study ID Numbers: V211-019
MKV211-019
2007_008
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

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