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ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)

This study is currently recruiting participants.
Verified June 2012 by Merck
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01600079
First received: May 14, 2012
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants.


Condition Intervention
Herpes Zoster
Shingles
 Biological: ZOSTAVAX™

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, ≥70) at Vaccination [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Severe Herpes Zoster Including Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, ≥70) at Vaccination [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Incidence of Severe Herpes Zoster Including Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30000
Study Start Date: May 2012
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vaccinated Cohort
Participants vaccinated with at least one dose of ZOSTAVAX™
 Biological: ZOSTAVAX™
ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use
Other Name: Zoster Vaccine Live
Unvaccinated Comparison Cohort
Matched participants who are not vaccinated with any zoster vaccine

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Members of Kaiser Permanente Northern California (KPNC)

Criteria

Inclusion Criteria:

  • Member of Kaiser Permanente Northern California (KPNC)

  • Vaccinated Cohort

    • Participants,
    • ≥ 50 years of age,
    • Vaccinated with at least one dose of ZOSTAVAX™

  • Unvaccinated Comparison Cohort

    • Matched participants,
    • ≥ 50 years of age,
    • Not vaccinated with any zoster vaccine

Exclusion Criteria:

  • < 12 months continuous KPNC membership prior to vaccination; and
  • age < 50 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600079

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, California
Investigational Site Recruiting
Oakland, California, United States, 94612
Sponsors and Collaborators
Merck
Kaiser Permanente
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01600079     History of Changes
Other Study ID Numbers: V211-024
Study First Received: May 14, 2012
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Merck:
Varicella-zoster vaccine
herpes zoster
shingles
Varicella-zoster virus
 postherpetic neuralgia
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

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

ClinicalTrials.gov processed this record on May 22, 2013