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

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ClinicalTrials.gov Identifier: NCT01556451
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : September 23, 2013
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Shingles Biological: Zoster Vaccine Live Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody [ Time Frame: 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).

  2. Geometric Mean Titer (GMT) of VZV Antibody [ Time Frame: 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

  3. Percentage of Participants With Clinical Adverse Experiences [ Time Frame: 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.

  4. Percentage of Participants Discontinued Due to Clinical Adverse Experiences [ Time Frame: Up to 42 days postvaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01556451     History of Changes
Other Study ID Numbers: V211-034
First Posted: March 16, 2012    Key Record Dates
Results First Posted: September 23, 2013
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs