Overview

This trial is active, not recruiting.

Conditions herpes zoster, shingles
Treatment zostavax™
Phase phase 4
Sponsor Merck Sharp & Dohme Corp.
Collaborator Kaiser Permanente
Start date May 2012
End date October 2023
Trial size 30000 participants
Trial identifier NCT01600079, 8003.016, V211-024

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Participants vaccinated with at least one dose of ZOSTAVAX™
zostavax™ Zoster Vaccine Live
ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use
Participants who are not yet vaccinated with any zoster vaccine

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 50 years old.

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:

Additional Information

Official title Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..