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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01527370
First received: February 2, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Herpes Zoster
Shingles
Biological: Zoster Vaccine Live
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination [ Time Frame: Prevaccination up to 6 weeks postvaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 250
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoster Vaccine Live Biological: Zoster Vaccine Live
One approximately 0.65 mL injection subcutaneously on Day 1
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 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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01527370     History of Changes
Other Study ID Numbers: V211-025, CTRI/2012/08/002922
Study First Received: February 2, 2012
Results First Received: November 11, 2013
Last Updated: May 12, 2014
Health Authority: India: Central Drugs Standard Control Organization

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

ClinicalTrials.gov processed this record on July 22, 2014