Vaccines and Related Biological Products Advisory Committee
September 22 - 23, 2004 Meeting
Date and Time:
The meeting will be held on September 22, 2004, 8:15 am to 4:30 pm; and September 23, 2004, 9:00 am to 12:15 pm.
Location:
Holiday Inn - Select, 8120 Wisconsin Avenue, Bethesda, MD 20814, 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:
On September 22, 2004, the Committee will consider the safety and efficacy of a tetravalent meningococcal conjugate vaccine, Menactra, manufactured by Aventis Pasteur, Inc. On September 23, 2004, the Committee will hear an update on the phase 3 Thai trial of ALVAC vCP 1521 [Aventis Pasteur, Inc.] with AIDSVAX B/E [VaxGen, Inc.] for the prevention of HIV-1 infection.
Oral Presentations:
Between approximately 2:00 and 2:30 p.m. on September 22, and 10:15 a.m. and 10:45 a.m. on September 23 oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before September 16, 2004.
Closed Committee Deiberations:
On September 22, 2004 from 8:15 a.m. to 9:45 a.m. and on September 23, 2004 from 11:00 a.m. to 12:15 p.m. the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4) 552b(c)(6)).
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