1. Nelson Arboleda, MD, MPH Immunization Safety Office (ISO) Office of the Chief Science officer (OCSO/OD) Centers for Disease Control and Prevention (CDC) IVSS Integrated Vaccine Surveillance System

2. Pandemic Influena - Pilot Projects for a Vaccine Safety Active Surveillance System Active monitoring of Influenza Vaccine Safety using Telewatch Immunization Information Systems (IIS) Surveillance Project/State Registries Integrated Vaccine Surveillance System (IVSS)

3. IVSS - Evaluate system that can actively monitor, record, and analyze adverse events associated with the administration of a pandemic influenza vaccine. - Similarly to Telewatch system - effectiveness of various communication approaches - Encourage recipients to be alert for AEFI - Remind them to return to their clinic for fu assessment or a second vaccination.

4. Objectives – Pilot 1.Assess user acceptance of E daily reporting by monitoring response rates for enrolled vaccinees. 2.Assess feasibility and benefits of active electronic surveillance of seasonal influenza vaccinees.

5. IVSS - Study Update Tested system during two-week period in November 2007. Participants enrolled at four different Kaiser clinics (2 MD, VA, DC) upon receiving seasonal flu vaccine. Monitored their reported vaccine reactions. - Made daily “Diary Entry” by phone or online for 7 days following vaccination (5 mins). Made outbound follow-up calls to non-respondents. Displayed results in real-time on a secure website.

6. Participating Sites

8. Intake & Recruitment CATI: Computer Assisted Telephone Interview

9. Intake & Recruitment

10. Results - Majority of adult vaccinees who were approached – willing to participate 166/211 (79%) -Would same be true in a “real” vaccine monitoring situation where a new vaccine is being used? -Persons seeking vaccination are amenable to idea of reporting their vaccine reactions

11. Results - 77% of individuals who agreed to participate did so.

12. Results Completion Rates: - 77% (N=128) of individuals who agreed to participate did so. - On average participants reported for 3 days post- vaccination - 9% (N=15) completed the entire protocol – reporting symptoms daily for 7 days. -* Five people used > 1 method to report.

13. Results Reporting mechanism: - 37% IVR - 19% Internet - 22% CATI - 23% No data & not reached by CATI

19. Results

21. Observations & Limitations: - Create and pilot test a system for active monitoring of persons following influenza vaccination. - Target of >250 study participants = 168 1. Late Start up 3 IRBs - Flu Season Kaiser Clinics 2.

22. 2. Thanksgiving Holiday/Shopping

23. Recommendations Nationwide Pandemic vaccine monitoring 1.Early recruiting of participants – (October – Start of Vaccination Campaigns) 2. Test in more diverse array of vaccine settings (Inc Public Health Clinics, Private Physician offices as well as HMO Clinics). Other locations. 3.Perform usability/satisfaction survey at end of testing

24. Recommendations Nationwide Pandemic vaccine monitoring 4. Addtl System features to be tested: - Inclusion of email/text messaging - Inclusion of outgoing educational messages - Alternative identification scheme (Larger sample) - Coordinate/adapt system to “feed” VAERS – - For calculating rates of AEFI - Accommodate data coordination 5. In IVR system – Establish Transcription Process when persons verbally use “Other”.

25. System Benefits 1.Tool to track status of vaccinees in the days following vaccination. 2. Mechanisms to reassure vaccinees that their health is being closely monitored (Particularly when a new vaccine is being widely tested/used). 3. Rapid ID of AEFI (associated with vaccine lots or distribution points)

26. System Benefits 4. Collect information on ALL Vaccinees – not just those w Serious AEFI. 5.Deployment to and access from multiple locations. 6.Automatic alert and notification capabilities. 7. Accurate, real-time statistics on post- vaccination reactions.

27. Questions