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Vaccines

Record of Telephone Conversation - December 11, 2009 - Prevnar 13

System Info - 113578  SMITH, MICHAEL J  11-Dec-2009 12:42:11  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time:  11-DEC-2009 11:56 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
IR for narratives for AE's resulting in withdrawal and for serious related events post toddler dose and 6-month follow-up safety data from study 6096A1-3005.

FDA Participants:   Julie Vaillancourt, Colleen Sweeney and Mike Smith

Non-FDA Participants:   Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

______________________________________________

From:                     Vaillancourt, Julienne 
Sent:                      Friday, December 11, 2009 11:56 AM
To:                          'Devlin Carmel'; 'Love Jack'
Cc:                           Smith, Michael (CBER); Sweeney, Colleen
Subject:                 request for study 3005 post toddler dose narratives

Dear Jack and Carmel,

Dr. Tina Khoie has the following request:

Please submit narratives for the AE's resulting in withdrawal and for serious related events described in the December 2, 2009 amendment, which contained the post toddler dose and 6-month follow-up safety data from study 6096A1-3005.

Thank you.

Julie

Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Regulatory Reviewer
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration

Phone:    301-827-5414
Fax:        301-827-3532
E-mail:   julienne.vaillancourt@fda.hhs.gov

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW.  If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized.  If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.

End of telecon.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002