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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01556451
First received: February 17, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Shingles
Biological: Zoster Vaccine Live
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody [ Time Frame: Day 1 (Baseline) and Week 4 postvaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 (Baseline) and 4 weeks postvaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 42 days postvaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 42 days postvaccination ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoster Vaccine Live
Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
Biological: Zoster Vaccine Live
Zoster vaccine live
Other Names:
  • ZOSTAVAX™
  • V211

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556451

Locations
Korea, Republic of
MSD Korea Ltd.
Seoul, Korea, Republic of, 121-705
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01556451     History of Changes
Other Study ID Numbers: V211-034
Study First Received: February 17, 2012
Results First Received: July 19, 2013
Last Updated: September 10, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014