Vaccines and Related Biological Products Advisory Committee
March 15, 2005 Meeting
Date and Time:
The meeting will be held on March 15, 2005, 8:30 am to 5:40 pm.
Location:
Holiday Inn Select - Bethesda, 8120 Wisconsin Avenue, Bethesda, MD, 301-652-2000.
Contact Persons:
Christine Walsh, R.N., or Denise Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.
Agenda:
The Committee will review safety and immunogenicity for two Tetanus Toxoid, Reduced Diptheria Toxoid and Accellular Pertussis Vaccine, Adsorbed (Tdap) vaccines. In the morning, the Committee will review safety and immunogenicity data for a Tdap vaccine manufactured by GlaxoSmithKline Biologicals. In the afternoon, the Committee will review safety and immunogenicity data for a Tdap vaccine manufactured by Aventis Pasteur Ltd.
Oral Presentations:
Between approximately 11:10 and 11:40 am, and 4:10 and 4:40 pm, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person by March 8, 2005.
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