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

Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01600079
Enrollment
1505647
Registered
2012-05-16
Start date
2012-05-15
Completion date
2020-10-16
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster, Shingles

Keywords

Varicella-zoster vaccine, herpes zoster, shingles, Varicella-zoster virus, postherpetic neuralgia, Herpesviridae Infections, DNA Virus Infections, Virus Diseases

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.

Interventions

BIOLOGICALZOSTAVAX™

ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use

Sponsors

Kaiser Permanente
CollaboratorOTHER
Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination10 years
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination10 years

Secondary

MeasureTime frame
Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination10 years
Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination10 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026