
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

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End of telecon.
