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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 Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Herpes Zoster
Intervention Other: Choosing to receive the vaccine
Enrollment 170
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Patients Who Received the Herpes Zoster Vaccine Patients Who Declined the Herpes Zoster Vaccine
Hide Arm/Group Description These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free. These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.
Period Title: Overall Study
Started 100 66
Completed 100 66
Not Completed 0 0
Arm/Group Title Survey Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 166
Hide Baseline Analysis Population Description
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.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 166 participants
68  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants
Female
94
  56.6%
Male
72
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 166 participants
166
1.Primary Outcome
Title Answers to Survey Questions
Hide Description 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.
Time Frame January 9, 2012 to February 12, 2012
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Received the Herpes Zoster Vaccine Patients Who Declined the Herpes Zoster Vaccine
Hide Arm/Group Description:
Patients who chose to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
Overall Number of Participants Analyzed 100 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of responders
Subject reported receiving flu Vaccine last year
89
(83 to 95)
71.2
(60 to 82)
Reported would receive the vaccine if recommended
98
(95 to 100)
74
(64 to 85)
Time Frame 3 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Subjects Who Received the Herpes Zoster Vaccine Subjects Who Declined the Herpes Zoster Vaccine
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Subjects Who Received the Herpes Zoster Vaccine Subjects Who Declined the Herpes Zoster Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Who Received the Herpes Zoster Vaccine Subjects Who Declined the Herpes Zoster Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Who Received the Herpes Zoster Vaccine Subjects Who Declined the Herpes Zoster Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/100 (11.00%)      0/0    
Skin and subcutaneous tissue disorders     
Injection Site Reaction  11/100 (11.00%)  11 0/0  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Elisabeth J. Cohen
Organization: NYU Langone Medical Center
Phone: 212-263-3262
Publications:
Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01483378     History of Changes
Other Study ID Numbers: 11-02029
First Submitted: November 18, 2011
First Posted: December 1, 2011
Results First Submitted: February 19, 2013
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013