NCT01600079

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,505,647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

May 15, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

8.4 years

First QC Date

May 14, 2012

Last Update Submit

July 12, 2022

Conditions

Herpes ZosterShingles

Keywords

Varicella-zoster vaccineherpes zostershinglesVaricella-zoster viruspostherpetic neuralgiaHerpesviridae InfectionsDNA Virus InfectionsVirus Diseases

Outcome Measures

Primary Outcomes (2)

  • Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination

    10 years

  • Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination

    10 years

Secondary Outcomes (2)

  • 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

Study Arms (2)

Vaccinated Cohort

Participants vaccinated with at least one dose of ZOSTAVAX™

Biological: ZOSTAVAX™

Unvaccinated Comparison Cohort

Participants who are not yet vaccinated with any zoster vaccine

Interventions

ZOSTAVAX™BIOLOGICAL

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

Also known as: Zoster Vaccine Live
Vaccinated Cohort

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Members of Kaiser Permanente Northern California (KPNC)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Effectiveness of the live zoster vaccine during the 10 years following vaccination: real world cohort study using electronic health records. BMJ. 2023 Nov 8;383:e076321. doi: 10.1136/bmj-2023-076321.

    PMID: 37940142DERIVED

  • Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention. Vaccine. 2019 Aug 23;37(36):5422-5427. doi: 10.1016/j.vaccine.2019.07.004. Epub 2019 Jul 10.

    PMID: 31301920DERIVED

  • Baxter R, Bartlett J, Fireman B, Marks M, Hansen J, Lewis E, Aukes L, Chen Y, Klein NP, Saddier P. Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study. Am J Epidemiol. 2018 Jan 1;187(1):161-169. doi: 10.1093/aje/kwx245.

    PMID: 29309521DERIVED

MeSH Terms

Conditions

Herpes ZosterChickenpoxNeuralgia, PostherpeticHerpesviridae InfectionsDNA Virus InfectionsVirus Diseases

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionInfectionsNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

May 15, 2012

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share