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

NCT ID: NCT01556451

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-10-31

Brief Summary

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.

Conditions

Herpes Zoster; Shingles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Zoster Vaccine Live

Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1

Group Type: EXPERIMENTAL

Zoster Vaccine Live

Intervention Type: BIOLOGICAL

Zoster vaccine live

Interventions

Zoster Vaccine Live

Zoster vaccine live

Intervention Type: BIOLOGICAL

Other Intervention Names

ZOSTAVAX™; V211

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Choi WS, Choi JH, Choi JY, Eom JS, Kim SI, Pai H, Peck KR, Sohn JW, Cheong HJ. Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX) in Korean Adults. J Korean Med Sci. 2016 Jan;31(1):13-7. doi: 10.3346/jkms.2016.31.1.13. Epub 2015 Dec 24.

Reference Type: RESULT

PMID: 26770032 (View on PubMed)

Other Identifiers

V211-034

Identifier Type: -

Identifier Source: org_study_id