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

Phase 4

Completed

• Conditions: Shingles; Herpes Zoster
• Interventions: Biological: Zoster Vaccine Live

• Registration Number: NCT01556451
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Study Start: 2012-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-07-19
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-09-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoster Vaccine Live	Zoster Vaccine Live	Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1

Primary Outcome Measures

Name	Time	Method
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody	Day 1 (Baseline) and Week 4 postvaccination	Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).
Geometric Mean Titer (GMT) of VZV Antibody	Day 1 (Baseline) and 4 weeks postvaccination	Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
Percentage of Participants With Clinical Adverse Experiences	Up to 42 days postvaccination	An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Percentage of Participants Discontinued Due to Clinical Adverse Experiences	Up to 42 days postvaccination