
Telecon PMC January 25, 2010 - Menveo



 
 
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  

Product:
 Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Applicant:                                                                       
 Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  25-JAN-2010 04:16 PM                Initiated by FDA?  Yes
 Telephone Number:    

Communication Categorie(s):
 1. Advice
 2. Labeling via FAX/e-mail
 3. Other

Author:  ELIZABETH VALENTI

Telecon Summary:
 Acceptance of Safety PMC completion date.
 Proposed PMC for concom immune interference
 No further comments on carton & container

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

  
 Related STNs:  None

Related PMCs:  None

Telecon Body:
From: Valenti, Elizabeth
Sent: Monday, January 25, 2010 4:16 PM
To: 'christopher.webster@novartis.com'
Cc: Fiore, Cara; Valenti, Elizabeth
Subject: RE: PVP Date
Importance: High
 Chris,

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
