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CompletedNCT01600079Updated Jul 14, 2022

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

An observational study in Herpes Zoster and Shingles, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,505,647
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Herpes Zoster
  • Shingles

Keywords

  • Varicella-zoster vaccine
  • herpes zoster
  • shingles
  • Varicella-zoster virus
  • postherpetic neuralgia
  • Herpesviridae Infections
  • DNA Virus Infections
  • Virus Diseases
03

In context

Herpes Zoster

370 studies on the registry are indexed under Herpes Zoster; 63 are open to participants now.

This study's enrollment of 1,505,647 is above the median of 355 across 51 observational studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Members of Kaiser Permanente Northern California (KPNC)

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

Exclusion Criteria:

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,505,647 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BiologicalZOSTAVAX™

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

    Also known as: Zoster Vaccine Live

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 10 years

Secondary outcomes

  1. 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

  2. Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination

    Time frame: 10 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 37940142 ↗
  • 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. PubMed 31301920 ↗
  • 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. PubMed 29309521 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01600079
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Kaiser Permanente
Responsible party
Sponsor
First posted
May 16, 2012
Start date
May 15, 2012
Primary completion
Oct 16, 2020
Completion
Oct 16, 2020
Last update
Jul 14, 2022

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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