Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

March 15, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

AGENDA

8:30 a.m. Call to Order Gary Overturf, M.D., Chair

8:35 Administrative Matters Christine Walsh, R.N., FDA

Session 1 – Open Committee Discussion – Safety and Immunogenicity for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) manufactured by GlaxoSmithKline Biologicals

8:45 Tdap Introduction/Background/ Theresa Finn, Ph.D., FDA

Presentation of Questions

9:00 Clarifications/Questions

9:05 GSK Tdap/Boostrix™ GlaxoSmithKline

10:05 Clarifications/Questions

10:15 Break

10:30 FDA Presentation Ann Schwartz, M.D., FDA

11:00 Clarifications/Questions

11:10 Open Public Hearing

11:40 Committee Discussion and Recommendations

12:40 p.m. Lunch

Session ll – Open Committee Discussion – Safety and Immunogenicity data for Tdap

vaccine manufactured by Aventis Pasteur, Ltd.

1:45 ADACEL™ Introduction Martha Monser, FDA

1:55 AP Tdap/ADACEL™ Aventis Pasteur, Ltd.

2:55 Clarifications/Questions

Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

March 15, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

AGENDA

3:05 Break

3:20 FDA Presentation ChrisAnna Mink, M.D., FDA

4:00 Clarifications/Questions

4:10 Open Public Hearing

4:40 Committee Discussion and Recommendation

5:40 Adjourn Meeting