ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Shingles

Herpes Zoster

Treatments

Biological: Zoster Vaccine Live

Study type

Interventional

Funder types

Industry

Identifiers

NCT01556451

V211-034

Details and patient eligibility

About

This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.

Enrollment

180 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

No fever on day of vaccination
Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
Underlying chronic illness must be stable

Exclusion criteria

History of hypersensitivity reaction to any vaccine component
Prior history of herpes zoster
Prior receipt of varicella or zoster vaccine
Pregnant or breastfeeding
Have recently received immunoglobulins or blood products other than autologous blood transfusion
Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study
Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study
Use of immunosuppressive therapy
Known or suspected immune dysfunction
Use of nontopical antiviral therapy with activity against herpes virus
Known or suspected active untreated tuberculosis