Varicella Virus Infection
Conditions
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.
Interventions
BIOLOGICALZoster Vaccine, Live, (Oka-Merck)
A single dose of 0.65 ml of Zostavax injection was given to each study subject
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed