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

NCT ID: NCT01600079

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1505647 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-15

Study Completion Date

2020-10-16

Brief Summary

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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

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Conditions

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Herpes Zoster Shingles

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinated Cohort

Participants vaccinated with at least one dose of ZOSTAVAX™

ZOSTAVAX™

Intervention Type BIOLOGICAL

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

Unvaccinated Comparison Cohort

Participants who are not yet vaccinated with any zoster vaccine

No interventions assigned to this group

Interventions

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ZOSTAVAX™

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Zoster Vaccine Live

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type DERIVED
PMID: 37940142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31301920 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29309521 (View on PubMed)

Other Identifiers

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8003.016

Identifier Type: OTHER

Identifier Source: secondary_id

V211-024

Identifier Type: -

Identifier Source: org_study_id

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