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

Herpes Zoster Clinical Trial

Official title:

An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556451
• Other study ID #: V211-034
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2012
• Last updated: September 11, 2015
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

Intervention

Biological:
• Zoster Vaccine Live
Zoster vaccine live

Locations

Country	Name	City	State
Korea, Republic of	MSD Korea Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody	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).	Day 1 (Baseline) and Week 4 postvaccination	No
Primary	Geometric Mean Titer (GMT) of VZV Antibody	Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV	Day 1 (Baseline) and 4 weeks postvaccination	No
Primary	Percentage of Participants With Clinical Adverse Experiences	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.	Up to 42 days postvaccination	Yes
Primary	Percentage of Participants Discontinued Due to Clinical Adverse Experiences		Up to 42 days postvaccination	Yes