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

Completed

• Conditions: Shingles; Herpes Zoster
• Interventions: Biological: ZOSTAVAX™

• Registration Number: NCT01600079
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-14
• Study Start: 2012-05-15
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1505647

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated Cohort	ZOSTAVAX™	Participants vaccinated with at least one dose of ZOSTAVAX™

Primary Outcome Measures

Name	Time	Method
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination	10 years
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination	10 years

Secondary Outcome Measures

Name	Time	Method
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