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Real-time Influenza Vaccine Surveillance

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ClinicalTrials.gov Identifier: NCT01233388
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : June 12, 2012
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University

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.

Condition or disease Intervention/treatment
Vaccine Safety Other: Text message surveillance

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 400 participants
Time Perspective: Prospective
Official Title: Real-time Influenza Vaccine Surveillance: FLUNET
Study Start Date : November 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot

Group/Cohort Intervention/treatment
Text message surveillance
enroll for text message surveillance
Other: Text message surveillance
Text message surveillance for vaccine adverse events
Other Name: Flunet




Primary Outcome Measures :
  1. Number of participants who report a health symptom within 6 weeks of vaccination [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Sensitivity of the patient reporting compared to medical record [ Time Frame: 6 weeks ]
    We will compare information provided by participants for moderate-to-severe health problems with the medical record to determine sensitivity of reporting.

  2. Specificity of the patient reporting compared to medical record [ Time Frame: 6 weeks ]
    We will compare information provided by participants for moderate-to-severe health problems with the medical record to determine specificity of reporting.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric, adult and OB patiente receiving an influenza vaccine
Criteria

Inclusion Criteria:

  • Have an active cell phone with text messaging capability
  • Presents for care at participating sites
  • Fluent in English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233388


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Philip LaRussa, MD Columbia University
Principal Investigator: Melissa Stockwell, MD MPH Columbia University

Responsible Party: Melissa Stockwell, MD, MPH, Asst Prof of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01233388     History of Changes
Other Study ID Numbers: AAAD1619
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs