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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:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01527370
First received: February 2, 2012
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Geometric mean titer (GMT) of varicella zoster virus (VZV) antibody [ Time Frame: Prevaccination and 6 weeks postvaccination ] [ Designated as safety issue: No ]
  • Geometric mean fold rise (GMFR) in VZV antibody titers [ Time Frame: Prevaccination to 6 weeks postvaccination ] [ Designated as safety issue: No ]
  • Number of participants with serious adverse events [ Time Frame: Up to 42 days postvaccination ] [ Designated as safety issue: Yes ]

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01527370     History of Changes
Other Study ID Numbers: V211-025
Study First Received: February 2, 2012
Last Updated: April 19, 2013
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 May 22, 2013