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NCT01600079 Clinical Trial

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

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01600079
Other study ID # V211-024
Secondary ID 8003.016
Status Completed
Phase
First received
Last updated
Start date May 15, 2012
Est. completion date October 16, 2020

Study information
Verified date July 2022
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1505647
Est. completion date October 16, 2020
Est. primary completion date October 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC Kaiser Permanente

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 =80) at Vaccination 10 years
Primary Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination 10 years
Secondary Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, =80) at Vaccination 10 years
Secondary Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination 10 years
See also
  Status Clinical Trial Phase
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Completed NCT01165203 - Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects Phase 2
Recruiting NCT06088745 - A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine Phase 3
Completed NCT01385566 - A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2) Phase 1
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Completed NCT01911065 - T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020 Phase 4
Completed NCT00550745 - ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020) Phase 4
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Completed NCT00231816 - A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) Phase 3
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Active, not recruiting NCT04091451 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles Phase 3
Completed NCT02519855 - Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) Phase 3
Completed NCT04523246 - Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents Early Phase 1
Completed NCT05047770 - A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine Phase 3
Completed NCT03314103 - Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age Phase 3
Completed NCT01527370 - Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) Phase 3
Completed NCT01954251 - Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older Phase 3

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