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

Merck Sharp & Dohme (MSD) logo

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

180 participants in 1 patient group

Zoster Vaccine Live
Experimental group
Description:
Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Treatment:
Biological: Zoster Vaccine Live

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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