Product Approval Information

TELEPHONE CONFERENCE MEMORANDUM

STN 125254: CTD BLA for Influenza Virus Vaccine
SPONSOR: CSL Limited
PRODUCT: Influenza Virus Vaccine
DATE: June 29, 2007

CBER REPRESENTATIVE:
Katherine Berkhousen

CSL REPRESENTATIVE:
Paul Hartman
Tel: 610-878-4644
Fax: 610-878-4182

SUMMARY:

CBER requests additional clarification on the following items:

  1. Regarding Studies CSLCT-NHF-05-11, CSLCT-NHF-05-13, and CSLCT-NHF-04-99, you provided local and systemic (fever, chills, and malaise) reactogenicity data in your paper submission and datasets. However, we could not locate in the paper submission or in the datasets the characterization of the degree of intensity, mild, moderate, or severe, for each study subject. Please provide a summary of the proportions of subjects with mild, moderate, or severe reactogenicity events and the characterization of reactogenicity data for each subject as mild, moderate, or severe, or indicate where the data is located in the BLA submission.

  2. Please provide your plans for the submission of your culture confirmation study, your pediatric immune response and safety study, and your immune response and safety study in an at-risk adult population.

  3. It seems that there are two lot numbering systems in the BLA. The explanation in Section 3.2.S.2.2. M3, v. p.33 was provided only for the system 1. System 1 is where ----------------------------------------------, examples:

    4. 09061U2716   A/New Caledonia/20/99
    09062U2714   A/NY/55/04
    09063U2708   B/Jiangsu/10/03

    In the other system --------------------------------------. The digits are not the same for the H1, H3, and B virus strains in the two systems, examples:

    519505G03   A/New Caledonia
    519506G02   A/Panama/2007/99
    519507G01   B/Shangdong/7/97

    Please clarify. In addition, was the year of production, or sequential number of lot for each strain encoded in the lot number?

  4. Please submit the reports for the Preparation and Testing of Influenza Virus --- Seed lot of the A/Solomon Island/03/06 virus strain. It is missing in the section 3.2.S.2.3. Control Of Materials, M3, v.1 in Attachments.

  5. Please submit the Derivation and the passage history for the ----------------------- or indicate the Module and Volume in the BLA if it was already submitted.

 
Updated: February 22, 2008