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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: June 13, 2017
Last verified: June 2017
  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:


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, 70-79 ≥80) at Vaccination [ Time Frame: 10 years ]
  • Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination [ Time Frame: 10 years ]
  • Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination [ Time Frame: 10 years ]

Estimated Enrollment: 30000
Actual Study Start Date: May 15, 2012
Estimated Study Completion Date: October 30, 2023
Estimated Primary Completion Date: October 30, 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
Participants who are not yet vaccinated with any zoster vaccine

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Members of Kaiser Permanente Northern California (KPNC)
Criteria

Inclusion Criteria:

  • Participants with continuous Kaiser Permanente Northern California (KPNC) membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date

Exclusion Criteria:

  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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01600079     History of Changes
Other Study ID Numbers: V211-024
8003.016 ( Other Identifier: Merck )
Study First Received: May 14, 2012
Last Updated: June 13, 2017

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017