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Vaccines

Record of Telephone Conversation, December 16, 2009 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 16-Dec-2009 08:36 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY FRITZ
Telecon Summary:
Clarification of disposition for Study PSC04.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
Dr. Post-
 
Our review of Protein Sciences Corporation FluBlok BLA 125285 is ongoing. We have the following request for clarification:
 
1. Please clarify your disposition of subjects at Day 28 and Day 180. 
 
From the Interim Study Report (ISR), original BLA Module 5, Volume 19, pp 52-54, Table 4 p 53 and Table 14.1.1 p 105, and the corresponding electronic datasets, the disposition of subjects at Day 28 appears to be as presented in Table 1:
 
Table 1: Subject Disposition through Day 28 Contact – ISR-PSC04

 
Number of Subjects (%)
Treatment Group
Disposition
Placebo
n (%)
FluBlok
n (%)
FluBlok
Immunogenicity
Subset
n(%)
Randomized
2325 (100)
2323 (100)
391 (100)
Vaccinated*
2304 (100)
2344 (100)
391 (100)
Completed**
2211 (96%)
2249 (96%)
    0
Discontinued
    93 (4%)
    95 (4%)
    0
    Due to AE
      0
      0
 
    Lost to follow-up
    85 (4%)
    88 (4%)
 
    Withdrew consent
      2 (<1)
      7 (<1)
 
    Death
      0
      0
 
    Randomized, not
    Vaccinated
      0
      0
 
    Other reasons
      6 (<1)
      0
 
 
 
 
 
Safety Population
2304
2344
 
Evaluable 
Population (Immunogenicity)
 
 391
391

 
 
In the Complete (Final) Study Report (CSR), Complete Response Module 5, Volume 2, pp 55-58, Table 4 p56 and Table 14.1.1 p 158, and corresponding electronic datasets, the disposition of subjects at Day 180 appears to be as presented in Table 2:
 
Table 2: CSR – Final Disposition of Subjects through Day 180 – PSC04

 
#subjects(%)
 
 
 
 
Tx Gp
 
 
 
Disposition
Placebo
n (%)
FluBlok
n (%)
Overall
FluBlok
Immunogenicity
Subset
n(%)
Randomized
2325 (100)
2323 (100)
4648 (100)
480 (100)
Vaccinated*
2304 (100)
2344 (100)
4648 (100)
480 (100)
Completed**
2022   (88)
2049   (87)
4071   (88)
402   (84)   
Discontinued
 282   (12)
 295   (13)
 577   (12)
 78   (16)
    Due to AE
      3   (<1)
      3   (<1)
      6   (<1)
    0
    Lost to follow-up
 251   (11)
 260   (11)
 511   (11)
 73   (15)
    Withdrew consent
    14     (1)
    22     (1)
    36     (1)
    5     (1)
    Death
      1   (<1)
      1   (<1)
      2   (<1)
    0
    Randomized, not
    Vaccinated
      0
      0
      0
    0
    Other reasons
    13    (1)
      9   (<1)
    22   (<1)
    0
 
 
 
 
 
Safety Population
2304
2344
4648
 
Evaluable 
Population (Immunogenicity)
 
 448
 
448

            ***Serology available for immunogenicity analysis post database lock
 
Although the CSR appears to present the data through the end of the study, the report states in Section 10.1, paragraph 1, p55, Mod 5 Vol 2, that “The disposition of the 4648 subjects enrolled in the study as of the Day 28 contact is summarized in Table 4”, and then in paragraph 2, “No subjects died, and no subjects were discontinued due to AEs”. This latter sentence appears to refer to the Day 28 data, but paragraph 3 appears to describe subject disposition at the end of the study. Additionally, although Table 4, CSR p 56, Mod 5, Vol 2, is labeled “Subject Disposition through Day 28 Contact”, the data appears to represent the end of study data (Day 180). 
 
Please comment and provide a table(s) that presents the Disposition of Subjects at Day 28 versus Day 180. Please categorize discontinuations according to reason for discontinuation including: 
·               Due to AE
·               Lost to follow-up
·               Withdrew consent
·               Death
·               Randomized, not vaccinated
·               Other
 
If you have any questions, please contact the Regulatory Project Managers, Katherine Matrakas or Timothy Fritz, at 301-827-3070.
 
Thank you.
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/RRB2
WOC1 HFM-478 Suite 371N
1401 Rockville Pike
Rockville, MD 20852
Phone: 301-827-3070
Fax: 301-827-1597
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