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Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

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ClinicalTrials.gov Identifier: NCT01483378
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
New York University School of Medicine

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.

Condition or disease Intervention/treatment Phase
Herpes Zoster Other: Choosing to receive the vaccine Not Applicable

Detailed Description:
Patient vaccination behaviors will be assessed after 100 doses of the Zostavax vaccine are provided to underserved patients screened by ophthalmologists at the General Eye Clinic at a public hospital that does not normally provide the vaccine. A nurse will be at the clinic to administer the vaccine. Patients will be contacted by phone 1 month later and seen within 3 months in the Eye Clinic to determine whether there were any side effects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
Study Start Date : January 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Subjects who received the vaccine
Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it.
 Other: Choosing to receive the vaccine
No Intervention: Subjects who declined the vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Answers to Survey Questions [ Time Frame: January 9, 2012 to February 12, 2012 ]
    All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60 years of age or older
  • Absence of evidence of immune compromise in the medical record
  • Ability to speak and read English, Spanish or Chinese and give informed consent

Exclusion Criteria:

  • Vulnerable patients, including the cognitively impaired, prisoners and employee
  • FDA contraindications for Zostavax vaccine
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01483378


Locations
United States, New York
Bellevue Hospital
New York, New York, United States, 10016
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Merck Sharp & Dohme Corp.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01483378     History of Changes
Other Study ID Numbers: 11-02029
First Posted: December 1, 2011    Key Record Dates
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013
Last Verified: August 2013

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