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

Phase 3

Completed

• Conditions: Varicella Virus Infection
• Interventions: Biological: Zoster Vaccine, Live, (Oka-Merck)

• Registration Number: NCT00444860
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Zoster Vaccine, Live, (Oka-Merck)	Zostavax

Primary Outcome Measures

Name	Time	Method
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.	prevaccination and 4 weeks postvaccination