1. Influenza Vaccine Surveillance System Pilot Project Pandemic Influenza Vaccine: Doses Administered and Safety Training Conference Atlanta, GA—Aug. 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

2. Overview Background Objectives Methods Fall 2007 pilot program findings Fall 2008 expanded pilot program design

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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 Data Collection (If 3 days are missed) CATI Single Secure Database Enrollment/Intake Data Vaccinee Reported Data CATI Interview Data Real-time Reporting on Secure Study Website System-generated reports and charts Analytic Reporting SAS Programming, cross-tabs IVSS Pilot Procedures

11. IVSS Pilot 2007: Sample Data collection: Nov. 14–21, 2007 6 clinic days across 4 clinics N=166 vaccinees 26% overall refusal rate

12. IVSS Pilot 2007: No. 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.

13. IVSS Pilot 2007: No. Reports by Reporting Mode

14. IVSS Pilot 2007: No. Participants Reporting Reactions

15. 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

16. IVSS Expanded Pilot 2008 Washington DC and Boston metro areas Public health department flu clinics Target N=1,000 vaccinees total Reporting for 14 days post vaccination E-mail and CATI follow-up

17. 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

18. Thank you