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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who received the vaccine | Other | Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it. |
|
| Subjects who declined the vaccine | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choosing to receive the vaccine | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Answers to Survey Questions | 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. | January 9, 2012 to February 12, 2012 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital | New York | New York | 10016 | United States | ||
| NYU Langone Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21788078 | Background | Ghaznawi N, Virdi A, Dayan A, Hammersmith KM, Rapuano CJ, Laibson PR, Cohen EJ. Herpes zoster ophthalmicus: comparison of disease in patients 60 years and older versus younger than 60 years. Ophthalmology. 2011 Nov;118(11):2242-50. doi: 10.1016/j.ophtha.2011.04.002. Epub 2011 Jul 23. | |
| 19909942 | Background |
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We prospectively recruited eligible patients from the Bellevue Eye clinic until 100 patients were prescribed and received the vaccine. Recruitment occurred from January 9, 2012 to February 12, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Who Received the Herpes Zoster Vaccine | These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free. |
| FG001 | Patients Who Declined the Herpes Zoster Vaccine | These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
170 patients were enrolled in the study, however 2 met FDA contraindications for herpes zoster vaccination and 2 already received the vaccine, so only 166 were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Survey Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Answers to Survey Questions | 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. | Posted | Number | 95% Confidence Interval | Percentage of responders | January 9, 2012 to February 12, 2012 |
|
3 months
Adverse events were only collected and assessed for participants who received vaccine since there are no risks from the vaccine if the patient did not receive it.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Who Received the Herpes Zoster Vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reaction | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elisabeth J. Cohen | NYU Langone Medical Center | 212-263-3262 | elisabeth.cohen@nyumc.org |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| New York |
| New York |
| 10016 |
| United States |
| Hu AY, Strauss EC, Holland GN, Chan MF, Yu F, Margolis TP. Late varicella-zoster virus dendriform keratitis in patients with histories of herpes zoster ophthalmicus. Am J Ophthalmol. 2010 Feb;149(2):214-220.e3. doi: 10.1016/j.ajo.2009.08.030. Epub 2009 Nov 11. |
| 20439573 | Background | Hurley LP, Lindley MC, Harpaz R, Stokley S, Daley MF, Crane LA, Dong F, Beaty BL, Tan L, Babbel C, Dickinson LM, Kempe A. Barriers to the use of herpes zoster vaccine. Ann Intern Med. 2010 May 4;152(9):555-60. doi: 10.7326/0003-4819-152-9-201005040-00005. |
| 21238856 | Background | Lu PJ, Euler GL, Harpaz R. Herpes zoster vaccination among adults aged 60 years and older, in the U.S., 2008. Am J Prev Med. 2011 Feb;40(2):e1-6. doi: 10.1016/j.amepre.2010.10.012. |
| 15930418 | Background | Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84. doi: 10.1056/NEJMoa051016. |
| 20178416 | Background | Rimland D, Moanna A. Increasing incidence of herpes zoster among Veterans. Clin Infect Dis. 2010 Apr 1;50(7):1000-5. doi: 10.1086/651078. |
| Background | Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38 |
| 23394910 | Derived | Jung JJ, Elkin ZP, Li X, Goldberg JD, Edell AR, Cohen MN, Chen KC, Perskin MH, Park L, Cohen EJ. Increasing use of the vaccine against zoster through recommendation and administration by ophthalmologists at a city hospital. Am J Ophthalmol. 2013 May;155(5):787-95. doi: 10.1016/j.ajo.2012.11.022. Epub 2013 Feb 6. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
|
|
| 0 |
| 100 |
| 11 |
| 100 |
| EG001 | Subjects Who Declined the Herpes Zoster Vaccine | 0 | 0 | 0 | 0 |
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| D007239 | Infections |