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

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. Identifier: NCT01527370
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : December 30, 2013
Last Update Posted : September 18, 2018
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.

Condition or disease Intervention/treatment Phase
Herpes Zoster Shingles Biological: Zoster Vaccine Live Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
Actual Study Start Date : October 31, 2012
Actual Primary Completion Date : April 9, 2013
Actual Study Completion Date : April 9, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: Zoster Vaccine Live Biological: Zoster Vaccine Live
One approximately 0.65 mL injection subcutaneously on Day 1
Other Names:
  • V211

Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Publications of Results:
Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated Varicella-Zoster Virus Vaccine (ZOSTAVAX™) in Healthy Adults in India. J Assoc Physicians India. 2018;66:50-54.,%20Safety,%20And%20Tolerability%20Of%20Live%20Attenuated.pdf

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01527370     History of Changes
Other Study ID Numbers: V211-025
CTRI/2012/08/002922 ( Registry Identifier: CTRI )
First Posted: February 7, 2012    Key Record Dates
Results First Posted: December 30, 2013
Last Update Posted: September 18, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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