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Completed

NCT Number: NCT01600079

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

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.

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Key information

Conditions

Herpes Zoster Chickenpox DNA Virus Infections Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Shingles Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zostavax™

Biological

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

Other names: Zoster Vaccine Live

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
May 16, 2012
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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