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Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527370
First Posted: February 7, 2012
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
February 2, 2012
February 7, 2012
November 11, 2013
December 30, 2013
April 12, 2017
October 2012
April 2013   (Final data collection date for primary outcome measure)
  • The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination [ Time Frame: Prevaccination up to 6 weeks postvaccination ]
    Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
  • Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination [ Time Frame: Prevaccination up to 6 weeks postvaccination ]
    GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
  • Number of Participants With Serious Adverse Events [ Time Frame: Up to 42 days postvaccination ]
    A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
  • Geometric mean titer (GMT) of varicella zoster virus (VZV) antibody [ Time Frame: Prevaccination and 6 weeks postvaccination ]
  • Geometric mean fold rise (GMFR) in VZV antibody titers [ Time Frame: Prevaccination to 6 weeks postvaccination ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Up to 42 days postvaccination ]
Complete list of historical versions of study NCT01527370 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Herpes Zoster
  • Shingles
Biological: Zoster Vaccine Live
One approximately 0.65 mL injection subcutaneously on Day 1
Other Names:
  • ZOSTAVAX™
  • V211
Experimental: Zoster Vaccine Live
Intervention: Biological: Zoster Vaccine Live
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
April 2013
April 2013   (Final data collection date for primary outcome measure)

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 illnesses must be stable

Exclusion Criteria:

  • History of hypersensitivity reaction to any vaccine component
  • Prior receipt of a varicella or zoster vaccine
  • Prior history of herpes zoster
  • Have recently had another vaccination
  • Have recently received blood products other than autologous blood transfusion
  • Pregnant or breast feeding
  • Use of immunosuppressive therapy
  • Known or suspected immune dysfunction
  • Use of nontopical antiviral therapy with activity against herpesvirus
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
India
 
NCT01527370
V211-025
CTRI/2012/08/002922 ( Registry Identifier: CTRI )
No
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP