Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

September 22 and 23, 2004

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

 

AGENDA

 

 

 

Day 1

 

Open Session

 

Presentation of Tetravalent Meningococcal Conjugate Vaccine

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 Representatives

11:45 AM             Questions of Clarification for Applicant

12:00 PM            Break

12:15 PM             Clinical Review of Safety and Efficacy            Dr. Lucia Lee, FDA

1:00  PM             Questions of Clarification for FDA

 

1:15 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

September 22 and 23, 2004

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

 

AGENDA

 

 

 

Day 2

 

Open Session

           

Thailand HIV Vaccine Phase 3 Trial

Trial Sponsor:  Office of the Surgeon General, US Army

Products:  HIV-1 Recombinant Canarypox-Vectored Vaccine (ALVAC vCP1521) [Aventis Pasteur], and Recombinant gp120 B/E (CHO cells) with Alum [VaxGen]

 

 

9:00 AM            Call to Order                                                   Dr. Gary Overturf, Chair

9:05 AM            Announcements                                                Christine Walsh R.N., FDA

9:15 AM            Opening Remarks                                            Dr. Joseph Toerner, FDA

9:25 AM             Presentation by the Sponsor                                   Office of the Surgeon General,

                        Overview of Study RV144,                                US Army

Rationale for Proceeding with Phase III Study

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