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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01483378
First received: November 18, 2011
Last updated: August 7, 2013
Last verified: August 2013
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Herpes Zoster
Intervention: Other: Choosing to receive the vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients Who Received the Herpes Zoster Vaccine These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free.
Patients Who Declined the Herpes Zoster Vaccine These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.

Participant Flow:   Overall Study
    Patients Who Received the Herpes Zoster Vaccine     Patients Who Declined the Herpes Zoster Vaccine  
STARTED     100     66  
COMPLETED     100     66  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Survey Participants No text entered.

Baseline Measures
    Survey Participants  
Number of Participants  
[units: participants]
  166  
Age  
[units: years]
Mean ± Standard Deviation
 
Age     68  ± 15  
Gender  
[units: participants]
 
Female     94  
Male     72  
Region of Enrollment  
[units: participants]
 
United States     166  



  Outcome Measures

1.  Primary:   Answers to Survey Questions   [ Time Frame: January 9, 2012 to February 12, 2012 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Elisabeth J. Cohen
Organization: NYU Langone Medical Center
phone: 212-263-3262
e-mail: elisabeth.cohen@nyumc.org


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

Publications automatically indexed to this study:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01483378     History of Changes
Other Study ID Numbers: 11-02029
Study First Received: November 18, 2011
Results First Received: February 19, 2013
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board