Vaccines and Related Biological Products Advisory Committee
November 4-5, 1999 Meeting
Date and Time
The meeting will be held on November 4, 1999 from 8:00 am to 6:00 pm and on November 5, 1999 from 8:00 am to 4:00 pm.
Location
Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Avenue, Bethesda, MD, 301-652-2000
Contact Person
Nancy T. Cherry or Denise H. Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area), code 12391. Please call the Information Line for up-to-date information on this meeting.
Oral Presentations
On November 4, 1999 oral presentations from the public will be scheduled from approximately 11:30 to 11:45 am and 3:00 to 3:45 pm, and on November 5, 1999 from approximately 1:30 to 1:45 pm and 3:15 to 3:30 pm. Those desiring to make formal oral presentations should notify the contact person before October 28, 1999.
Agenda
On the morning of November 4, 1999 the committee will discuss ways to demonstrate attenuation of chimeric strains of
Cytomegaloviral candidate vaccines to support proceeding into clinical trials. In the afternoon, the committee will discuss
safety data following a fifth successive dose of DTaP (Tripedia) manufactured by Connaught Laboratories, Inc. On November 5, 1999 the product license application for Wyeth Lederle Vaccines and Pediatrics' Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 protein) will be discussed for use in infants and young children. The committee will be asked to consider the safety and efficacy of this vaccine against prevention of invasive disease (bacteremia and meningitis) caused by Streptococcus pneumoniae (pneumococcus).
Closed Committee Deliberations
On November 4, 1999 from 8:00 to 9:00 am and from approximately 1:30 to 2:00 pm the meeting will be closed
to the public to permit discussion and review of trade secret and/or confidential information. Also, on November 5,
1999 from approximately 8:00 to 9:00 am the meeting will be closed.
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