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

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ClinicalTrials.gov Identifier: NCT01600079
Recruitment Status : Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Herpes Zoster Shingles Biological: ZOSTAVAX™

Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™
Actual Study Start Date : May 15, 2012
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Group/Cohort Intervention/treatment
Vaccinated Cohort
Participants vaccinated with at least one dose of ZOSTAVAX™
Biological: ZOSTAVAX™
ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use
Other Name: Zoster Vaccine Live

Unvaccinated Comparison Cohort
Participants who are not yet vaccinated with any zoster vaccine



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Members of Kaiser Permanente Northern California (KPNC)
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600079


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Kaiser Permanente
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01600079     History of Changes
Other Study ID Numbers: V211-024
8003.016 ( Other Identifier: Merck )
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Varicella-zoster vaccine
herpes zoster
shingles
Varicella-zoster virus
postherpetic neuralgia
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs