Influenza Vaccine Surveillance System Pilot Project Pandemic Influenza Vaccine: Doses Administered a

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Influenza Vaccine Surveillance System Pilot
ProjectPandemic Influenza Vaccine Doses
Administered and Safety Training
ConferenceAtlanta, GAAug. 22, 2008

• Gabriella Newes-Adeyi, PhD, MPH
• Andrea Hassol, MSPH
• Margarita Warren, MPA
• Abt Associates, Inc.
• Nelson Arboleda, MD, MPH
• Centers for Disease Control and Prevention

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Overview

• Background
• Objectives
• Methods
• Fall 2007 pilot program findings
• Fall 2008 expanded pilot program design

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Background Abt Associates Inc.

• Social science research firm founded in 1965
• Focus on research, program evaluation, analysis
  of social problems, programs and policies
• Extensive experience with multi-modal data
  collection, vaccine research, influenza research

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Background Abt Smallpox Study for DoD (2003)

• Abt, in collaboration with Voxiva, Inc.,
  developed innovative surveillance system to
  monitor DoD smallpox vaccination program
• Following vaccination, vaccinees registered and
  received a diary reporting card
• Diary reporting card had photographic list of
  evolving vaccination site and potential symptoms
• Vaccinees called or logged in to electronic diary
  over 28 day period to report how the site
  appeared and any symptoms or concerns
• Call center follow-up on non-reporters

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Influenza Vaccine Surveillance System (IVSS)

• CDC contracted with Abt Associates to conduct
  pilot program
• Pilot program conducted in Fall 2007
• Expanded pilot program planned for Fall 2008

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Why an Influenza Vaccine Surveillance System?

• CDC needs
• Easy-to-use tool to track vaccinee status post
  influenza vaccination
• Mechanism to reassure vaccinees that their health
  is monitored
• Rapid identification of vaccine reactions
• Ability to collect information on all vaccinees
• Deployment to and access from multiple locations
• Automatic alert and notification capabilities
• Accurate, real-time statistics on
  post-vaccination reactions

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IVSS Pilot Program Objectives (1)

• Primary objectives
• Assess user acceptance of electronic daily
  reporting by monitoring response rates for
  enrolled vaccinees
• Assess feasibility and benefits of active
  electronic surveillance of seasonal influenza
  vaccinees

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IVSS Pilot Program Objectives (2)

• Secondary objectives
• Assess call-back procedures and procedures for
  different population groups
• Provide pro-active monitoring of vaccine effects
  to assure recipients of their safety for seasonal
  influenza vaccine
• Assess feasibility and mechanism for integrating
  reported data for adverse events into VAERS

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IVSS Pilot 2007 Methods

• Four Kaiser Permanente clinics in Washington DC
  metropolitan area
• Flu shots during walk-in and primary care visits
• Two recruiters/site two days per clinic location
• Vaccine lot numbers obtained from clinics
• Vaccinees asked to report daily for one week (7
  days) via web or telephone call
• Follow-up calls made to non-responders

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IVSS Pilot Procedures
Recruitment Step 1 Vaccinee arrives at clinic
and is directed to flu shot location/room Step
2 Vaccinee is approached by recruiter Step 3
If Vaccinee agrees to participate s/he signs
consent and gives recruiter demographic and
contact information Step 4 Recruiter completes
intake online if there is wifi connectivity, or
in laptop, or on paper (if laptop failed) and
assigns participant password Step 5 Participant
receives a wallet card with the study website and
toll-free number, and a list of common influenza
vaccine reactions Step 6 Wifi program checks
for connectivity and uploads completed intake
records to the database (if no wifi connection,
records are entered manually at end of day)
Daily Data Collection IVR WEB
Single Secure Database Enrollment/Intake
Data Vaccinee Reported Data CATI Interview
Data
Data Collection (If 3 days are missed) CATI
Real-time Reporting on Secure Study
Website System-generated reports and charts
Analytic Reporting SAS Programming, cross-tabs
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IVSS Pilot 2007 Sample

• Data collection Nov. 1421, 2007
• 6 clinic days across 4 clinics
• N166 vaccinees
• 26 overall refusal rate

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IVSS Pilot 2007No. Participants by Duration of
Reporting
A few participants continued reporting beyond
one week. Anyone who missed three daily reports
was telephoned these CATI data are included in
table.
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IVSS Pilot 2007 No. Reports by Reporting Mode
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IVSS Pilot 2007 No. Participants Reporting
Reactions
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Summary and Conclusions

• Due to small sample size, results must be
  interpreted with caution
• Vaccinees are willing to report in on vaccine
  reactions
• Offering IVR and Web-based options preferable
• Having CATI follow-up for non-responders
  increases response rates

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IVSS Expanded Pilot 2008

• Washington DC and Boston metro areas
• Public health department flu clinics
• Target N1,000 vaccinees total
• Reporting for 14 days post vaccination
• E-mail and CATI follow-up

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Potential Applications/Usage

• Pandemic influenza monitoring adverse events
• Provides denominator of all vaccinees
• Linking vaccinees reporting adverse events to
  health care providers
• Using system to send vaccination-related health
  education messages (e.g., e-mail, text messages,
  voicemail) to vaccinees

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Thank you