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Real-time Influenza Vaccine Surveillance

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01233388
First received: October 29, 2010
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Vaccine Safety
 Other: Text message surveillance

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Real-time Influenza Vaccine Surveillance: FLUNET

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of participants who report a health symptom within 6 weeks of vaccination [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Sensitivity of the patient reporting compared to medical record [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    We will compare information provided by participants for moderate-to-severe health problems with the medical record to determine sensitivity of reporting.

  • Specificity of the patient reporting compared to medical record [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    We will compare information provided by participants for moderate-to-severe health problems with the medical record to determine specificity of reporting.


Enrollment: 400
Study Start Date: November 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Text message surveillance
enroll for text message surveillance
 Other: Text message surveillance
Text message surveillance for vaccine adverse events
Other Name: Flunet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Melissa Stockwell, MD, MPH, Asst Prof of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01233388     History of Changes
Other Study ID Numbers: AAAD1619
Study First Received: October 29, 2010
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013