System Info - 101802 SWEET, EBONY 10-Aug-2009 12:39:36 SWEETEB
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125300/0 Office: OVRR
Meningococcal ACWY Conjugate Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 10-AUG-2009 09:49 AM Initiated by FDA? Yes
2. Information Request
Author: CARA FIORE
PVP for Menveo; See EDR for details
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fiore, Cara
Sent: Monday, August 10, 2009 9:49 AM
Cc: Valenti, Elizabeth
Subject: PVP for Menveo
Please see comments below for your pharmacovigilance plan.
In general, we concur with the use of a self-controlled case series method for evaluating post-marketing adverse events after MenACWY. When you submit your protocol for CBER review, please address the following comments:
- Please propose clinically meaningful (recognizing power constraints) endpoints/criteria for evaluating each EOI and EOI grouping (e.g., the lower bound of the 95% confidence interval for relative incidence (risk/control interval) is < 1.00).
- Please clarify your plans for analyzing individual EOIs within an EOI group (e.g., encephalitis within the new onset neurological events grouping).
- Please specify the timeframe for risk and control intervals for each EOI.
- Please clarify the risk interval duration definition (e.g., time from vaccination to onset of the first symptom related to the specific EOI).
- Please comment on how a new suspected EOI (i.e., not included in the initial protocol) could be evaluated using the same study framework.
- Please comment on how you would evaluate safety in ages outside of the inclusion criterion age range of 11-19 years if the Advisory Committee on Immunization Practices expands the recommended age for routinely receiving meningococcal conjugate vaccine.
- Please propose a deadline for submission of the final study report.
- Please provide interim study reports at least annually within each annual periodic adverse experience report (PAER) until the final study report is submitted to CBER.
- Please specify procedures and thresholds for early analysis and reporting to CBER (e.g., for a serious unexpected adverse event with a high relative incidence).
Cara Fiore, Ph D
Division of Vaccines and Related Products Applications
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
U.S. Food & Drug Administration
WOC1 RM300N HFM-481
1401 Rockville Pike
Rockville, MD 20852