NCT01600079CompletedNot Applicable
Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,505,647
- Primary Endpoint
- Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Outcomes
Primary Outcomes
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
Time Frame: 10 years
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
Secondary Outcomes
- Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination(10 years)
- Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination(10 years)
Investigators
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