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Record of Telephone Conversation, July 15, 2008 - Flublok
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Product: Influenza Vaccine
Applicant: Protein Sciences Corporation
Telecon Date/Time: 15-Jul-2008 01:48 PM Initiated by FDA? Yes
Communication Category: Information Request
Author: RAKESH PANDEY
PSC04 samples labs; PSC06 Primary hypothesis and request for serology data
FDA Participants: Rakesh Pandey
Non-FDA Participants: Manon Cox and Penny Post
Here are the questions discussed today. Please respond to these questions:
- In response to statistical Question #1, you mentioned that serum samples from five sites were sent to the central laboratories. Please explain to how many central laboratories these samples were sent to.
- Seroconversion and seroprotection hypotheses are primary hypotheses related to FluBlok (please see your primary hypotheses in the Statistical Analysis Plan, pages 9 and 10). You discussed results for primary hypotheses in Paragraph 11.1 and summarized them in Tables 54 and 64 (Interim Clinical Report - pages 50 to 52). However, in Paragraph 11.1, you evaluated not only immunogenicity of FluBlok vaccine but also immunogenicity of Fluzone vaccine. Please note that the non-inferiority comparisons of Flublok and Fluzone vaccines are secondary hypotheses and should be discussed in a different paragraph. Please present results related to the primary hypotheses clearly in a separate paragraph.
- You supplied serology data (sero.sas7bdat) for immunogenicity analyses. However, for baseline titers smaller than 10, you have indicated the titers values as “<10,” rather than providing an imputed value. Please note that the statistical reviewer needs baseline titers. Please send to the FDA the updated baseline serology data as soon as possible, with imputed titer values included for baseline titers <10.