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

NCT01556451 | Completed Phase 4 Results

• 1 other identifier: V211-034
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Percentage of Participants Discontinued Due to Clinical Adverse Experiences

  Up to 42 days postvaccination

Study Arms (1)

Zoster Vaccine Live

EXPERIMENTAL

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

Biological: Zoster Vaccine Live

Interventions

Zoster Vaccine Live BIOLOGICAL

Zoster vaccine live

Also known as: ZOSTAVAX™, V211

Zoster Vaccine Live

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 26770032 RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 16, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 12, 2017
• Results First Posted: September 23, 2013

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share