System Info - 118665 VALENTI, ELIZABETH 27-Jan-2010 10:25:50 VALENTI
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125300/0 Office: OVRR
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 25-JAN-2010 04:16 PM Initiated by FDA? Yes
2. Labeling via FAX/e-mail
Author: ELIZABETH VALENTI
Acceptance of Safety PMC completion date.
Proposed PMC for concom immune interference
No further comments on carton & container
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Valenti, Elizabeth
Sent: Monday, January 25, 2010 4:16 PM
Cc: Fiore, Cara; Valenti, Elizabeth
Subject: RE: PVP Date
The review team agrees with extending the Phase 4 safety study completion date to August 20, 2015. However, we also have another postmarketing commitment that we would like agreement on:
to conduct a randomized, comparative trial, designed primarily to evaluate the potential for immune interference of concomitant use of MENVEO with U.S. licensed human papillomavirus vaccine and tetanus, reduced diphtheria, acellular pertussis vaccine as currently recommended for immunization of adolescents. You commit to providing a clinical protocol for CBER review by May 2010 and to providing complete study results by November 2012.
We have no further comments based upon the last mock-up of Menveo carton and container labels.
Please comment on immune interference PMC as soon as possible. Thank you, Betsy