Real-time Influenza Vaccine Surveillance

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
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 April 16, 2014