Status:
COMPLETED
ZOSTAVAX(R) Local Registration Trial (V211-019)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Varicella Virus Infection
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00444860
Start Date
March 1 2007
End Date
May 1 2007
Last Update
June 4 2015
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