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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

May 14, 2012
June 6, 2012
May 2012
October 2023   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01600079 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)
Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Members of Kaiser Permanente Northern California (KPNC)
  • Herpes Zoster
  • Shingles
Biological: ZOSTAVAX™
ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use
Other Name: Zoster Vaccine Live
  • Vaccinated Cohort
    Participants vaccinated with at least one dose of ZOSTAVAX™
    Intervention: Biological: ZOSTAVAX™
  • Unvaccinated Comparison Cohort
    Matched participants who are not vaccinated with any zoster vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30000
October 2023
October 2023   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact: Toll Free Number 1-888-577-8839
United States
 
NCT01600079
V211-024
Yes
Merck
Merck
Kaiser Permanente
Not Provided
Merck
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP