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Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00109122
First Posted: April 25, 2005
Last Update Posted: March 15, 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.
  Purpose
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Condition Intervention Phase
Shingles Biological: zoster vaccine live (Oka/Merck) Biological: Comparator: placebo (unspecified) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • VZV ELISPOT response ~6 weeks after 1 and 2 doses [ Time Frame: 6 weeks after 1 and 2 doses ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo [ Time Frame: 1 through 3 years after vaccination ]

Enrollment: 180
Study Start Date: November 2001
Study Completion Date: July 2006
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: zoster vaccine live (Oka/Merck)
    Other Name: V211
    Biological: Comparator: placebo (unspecified)
Detailed Description:
The duration of treatment is 12 weeks.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals who are at least 60 years of age with a history of varicella (shingles)
  • Females must have been postmenopausal.

Exclusion Criteria:

  • Subjects who did not previously participate in the main study of this protocol.
  • Subject had shingles since their 6 month follow-up visit in main phase of study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109122


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Study Data/Documents: CSR Synopsiis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109122     History of Changes
Other Study ID Numbers: V211-007
2005_017
First Submitted: April 22, 2005
First Posted: April 25, 2005
Last Update Posted: March 15, 2017
Last Verified: March 2017

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