Trial Outcomes & Findings for Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital (NCT NCT01483378)
NCT ID: NCT01483378
Last Updated: 2013-08-09
Results Overview
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.
COMPLETED
NA
170 participants
January 9, 2012 to February 12, 2012
2013-08-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
66
|
|
Overall Study
COMPLETED
|
100
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
Baseline characteristics by cohort
| Measure |
Survey Participants
n=166 Participants
|
|---|---|
|
Age Continuous
Age
|
68 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
166 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: January 9, 2012 to February 12, 2012All 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.
Outcome measures
| Measure |
Patients Who Received the Herpes Zoster Vaccine
n=100 Participants
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 the Herpes Zoster Vaccine
n=66 Participants
Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
|
|---|---|---|
|
Answers to Survey Questions
Subject reported receiving flu Vaccine last year
|
89 Percentage of responders
Interval 83.0 to 95.0
|
71.2 Percentage of responders
Interval 60.0 to 82.0
|
|
Answers to Survey Questions
Reported would receive the vaccine if recommended
|
98 Percentage of responders
Interval 95.0 to 100.0
|
74 Percentage of responders
Interval 64.0 to 85.0
|
Adverse Events
Subjects Who Received the Herpes Zoster Vaccine
Subjects Who Declined the Herpes Zoster Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Who Received the Herpes Zoster Vaccine
n=100 participants at risk
|
Subjects Who Declined the Herpes Zoster Vaccine
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
11.0%
11/100 • Number of events 11 • 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.
|
—
0/0 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60