Record of Telephone Conversation - October 6, 2009 - Prevnar 13

System Info - 111933  SMITH, MICHAEL J  23-Nov-2009 18:05:12  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:  06-OCT-2009 11:04 AM               Initiated by FDA?  Yes

Telephone Number:    

 

Communication Categorie(s):

Information Request

 

Author:  COLLEEN SWEENEY

 

Telecon Summary:

Email: IR for immunogenicity data for study 3005 and 008.

 

FDA Participants:   Julienne Vaillancourt, Tina Khoie and Michael Smith

 

Non-FDA Participants:    Carmel Devlin

 

Trans-BLA Group: No

    

Related STNs:  None

 

Related PMCs:  None

 

Telecon Body:

 

 ______________________________________________

From:            Sweeney, Colleen 

Sent:             Tuesday, October 06, 2009 11:04 AM

To:                'DEVLINC@wyeth.com'

Cc:                Vaillancourt, Julienne; Khoie, Tina; Smith, Michael (CBER)

Subject:         RE:  Request for data submission to STN: 125324 previously submitted to IND 11673

Importance:    High

 

Dear Carmel:

In regard to the telephone message I had left earlier this morning I just wanted to follow up with an e-mail:

On July 15, 2009, amendment 229 was submitted to IND –(b)(4)-. This amendment contained the following data:

1) New immunogenicity data from study 3005, including pneumococcal NI data (comparison of data from 3 pooled 13vPnC lots to the 1 7vPnC lot), post infant and toddler doses.

2) Toddler dose immunogenicity data (OPA and IgG) from study 008 to support the transition schedule from 7vPnC to 13vPnC.

Please submit this data to STN: 125324.

 

Thank you,

 

Colleen Sweeney

 

End of email