Real-time Influenza Vaccine Surveillance
1 other identifier
observational
400
1 country
1
Brief Summary
The aim of this proposal is to pioneer the implementation and evaluation of a novel patient centered text messaging vaccine adverse event surveillance network.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 12, 2012
June 1, 2012
1.5 years
October 29, 2010
June 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who report a health symptom within 6 weeks of vaccination
As this is a pilot study, we want to first determine if people will report health problems. Therefore, we will assess the number of participants who report a health problem within 6 weeks of vaccination.
6 weeks
Secondary Outcomes (2)
Sensitivity of the patient reporting compared to medical record
6 weeks
Specificity of the patient reporting compared to medical record
6 weeks
Study Arms (1)
Text message surveillance
enroll for text message surveillance
Interventions
Text message surveillance for vaccine adverse events
Eligibility Criteria
Pediatric, adult and OB patiente receiving an influenza vaccine
You may qualify if:
- Have an active cell phone with text messaging capability
- Presents for care at participating sites
- Fluent in English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Centers for Disease Control and Preventioncollaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Philip LaRussa, MD
Columbia University
- PRINCIPAL INVESTIGATOR
Melissa Stockwell, MD MPH
Columbia University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst Prof of Pediatrics
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 3, 2010
Study Start
November 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 12, 2012
Record last verified: 2012-06