Food And Drug Administration
Center For Biologics Evaluation And Research
Vaccines And Related Biological Products Advisory Committee Meeting
Draft AGENDA
9:45 AM Break/Adjourn Closed Session
Sponsor: Aventis Pasteur Inc.
Product: Menactra
10:00 AM Call to Order Dr. Gary Overturf, Chair
10:05 AM Announcements Christine Walsh R.N., FDA
10:15 AM Introduction to the License Application Dr. Carl Frasch, FDA
What is the product
Requested indication
Regulatory history
10:30 AM Clinical Data in Support of Menactra Aventis Pasteur Representative
11:15 AM Questions of Clarification for Applicant
11:30 AM Break
11:45 AM Clinical Review of Safety and Efficacy Dr. Lucia Lee, FDA
12:30 PM Questions of Clarification for FDA
12:45 PM Lunch
2:00 PM Open Public Hearing
2:30 PM Presentation of Questions for Committee Dr. Carl Frasch, FDA
2:45 PM Committee Discussion/Voting on Questions
3:30 PM Break
3:45 PM Continuation of Committee Discussion/Vote
4:30 PM Adjourn
Food And Drug Administration
Center For Biologics Evaluation And Research
Vaccines And Related Biological Products Advisory Committee Meeting
Draft AGENDA
Thailand HIV Vaccine
Phase 3 Trial
Trial Sponsor: Office of the Surgeon General of the Army
Products: HIV-1 Recombinant Canarypox-Vectored Vaccine
(ALVAC vCP1521) [Aventis Pasteur], and Recombinant gp120 B/E (CHO cells) with
Alum [VaxGen]
9:15 AM Opening Remarks Dr. Joseph Toerner, FDA
9:25 AM Presentation by the Sponsor LTC Brown, DoD
10:00 AM Questions of Clarification from Committee
10:15 AM Open Public Hearing
10:45 AM Break/Adjourn Open Session
11:00 AM Closed Session
12:15 PM Adjourn