VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 26-27, 2001
Aviron
Cold Adapted Influenza Vaccine, Trivalent - FluMistรค
Briefing Information
Sponsors Briefing Information
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Table of Contents pdf
List of Abbreviations pdf
List of Tables pdf
List of Figures pdf
1. Introduction pdf
2. Epidemiology and Prevention of Influenza pdf
3. Rational for FluMist Development pdf
4. FluMist Clinical Program pdf
5. Summary of Efficacy pdf
6. Summary of Immunogenicity pdf
7. Summary of Safety pdf
8. Overall Conclusions pdf
Appendices pdf
Appendix 1: Pre-Specified Medically Attended Events in Study AV019 pdf
Appendix 2: MAE Categories (N-147) Recorded in Hospital, ED, or Outpatient Clinic Databases for Study Participants during the Safety Evaluation Period in Study AV019 pdf