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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01600079
First received: May 14, 2012
Last updated: September 4, 2014
Last verified: September 2014
  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: Retrospective
Official Title: Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™

Resource links provided by NLM:


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

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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600079

Locations
United States, California
Call for Information (Investigational Site 0001)
Oakland, California, United States, 94612
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Kaiser Permanente
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01600079     History of Changes
Other Study ID Numbers: V211-024, 8003.016
Study First Received: May 14, 2012
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Merck Sharp & Dohme Corp.:
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 October 02, 2014