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Vaccines

Telecon, PVP Date, January 25, 2010 - Menveo

(System Info - 118907 SWEET EBONY 01/29/2010 07:56:50 SWEETEB)

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA    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 04:14 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice

Author: ELIZABETH VALENTI
Telecon Summary:
PVP Date
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:
From: Webster, Christopher [mailto:christopher.webster@novartis.com]
Sent: Friday, January 29, 2010 9:44 AM
To: Valenti, Elizabeth
Cc: Fiore, Cara
Subject: RE: PVP Date
Thank you, Betsy.

Chris

Chris Webster
Head, Regulatory Affairs, Meningitis
Novartis Vaccines and Diagnostics
Direct: (617) 871-4280
Cell: (617) 417-9583
Email: christopher.webster@novartis.com

 


From: Valenti, Elizabeth [mailto:Elizabeth.Valenti@fda.hhs.gov]
Sent: Friday, January 29, 2010 9:28 AM
To: Webster, Christopher
Cc: Fiore, Cara; Valenti, Elizabeth
Subject: RE: PVP Date
Hello Chris,

We agree to the protocol submission date of July, 2010.  This study needs to be conducted with U.S. licensed vaccines and on a U.S. vaccine administration schedule.  The locations can be discussed as the protocol is being developed and submitted.

Thank you, Betsy


From: Webster, Christopher [mailto:christopher.webster@novartis.com]
Sent: Wednesday, January 27, 2010 4:21 PM
To: Valenti, Elizabeth
Cc: Fiore, Cara
Subject: RE: PVP Date
Dear Betsy,

As promised on our call this morning, I am responding to you on the new PMC below.  In principle, we would agree to conduct this study, but would submit the protocol by the end of July, 2010.  In addition, we would like to conduct the study with US-licensed vaccines but outside the US (or, at least, partially outside the US).  We agree to the reporting date.

Please let me know whether these terms are agreeable.

Thanks,
Chris

Chris Webster
Head, Regulatory Affairs, Meningitis
Novartis Vaccines and Diagnostics
Direct: (617) 871-4280
Cell: (617) 417-9583
Email: christopher.webster@novartis.com


From: Valenti, Elizabeth [mailto:Elizabeth.Valenti@fda.hhs.gov]
Sent: Monday, January 25, 2010 4:14 PM
To: Webster, Christopher
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