Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
ID Biomedical Corporation of Quebec
Telecon Date/Time: 26-Feb-2013 10:19 PM Initiated by FDA? Yes
Telephone Number: email@example.com
1. Other -
Author: KIRK PRUTZMAN
GSK notified CBER of incomplete QPAN H5N1-002 datasets
FDA Participants: CARMEN COLLAZO
Non-FDA Participants: MICHAEL SCHWATZ, Dominique Barbeau, Donna Boyce
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Michael Schwartz [firstname.lastname@example.org]
Sent: Tuesday, February 26, 2013 10:19 PM
To: Collazo, Carmen
Cc: Dominique Barbeau; Donna Boyce
Subject: data package for Q-Pan -002 day 364
I’m providing an update on the Q-Pan -002, day 364 SAS datasets.
GSK inadvertently did not submit the complete study data package with the initial BLA submitted on February 22, 2012 for Q-Pan. In total, 42 final datasets for the 364 day analysis, which include the entire study data, as well as 71 eCRFs were not submitted as planned. Please be aware that the other documentation for Q-Pan -002, day 364 were fully submitted in the initial BLA, including the Clinical Study Report and Study Protocol. Please also note that the fully cleaned unsolicited AE dataset (WUNSOL) for the entire study (day 364) was submitted to CBER on November 6, 2012, after CBER asked to provide or indicate where to find the individual data listings (datasets) for Q-Pan -002 unsolicited AEs collected through day 364 (email, C. Collazo to M. Schwartz on October 15, 2012).
I’d also like to take this opportunity to further describe what was submitted for Q-Pan -002, day 182, as these data were not “fully clean”. The cleaning process resolves questions related to the data by resolving incomplete data, in addition to allowing the sponsor to gain clarification, details and confirmation of data, all via querying the investigators for the necessary information. The SAS datasets submitted for day 182 contained the data included in the day 42 CSR and the day 182 CSR annex report. The datasets submitted contained data that had undergone the cleaning process for data up to the primary (day 42) and secondary (day 182) endpoint analyses, however, additional data beyond these endpoints were not cleaned since the study was still ongoing. As an example, for the day 42 analysis the data were fully cleaned up to day 42. However, any data collection beyond day 42 was not fully cleaned at that time. Furthermore, for the day 182 analysis the data were fully cleaned up to day 182 and data collection beyond day 182 were not fully cleaned at that time.
GSK is currently evaluating and directly comparing the day 364 and 182 datasets in order to determine their differences. Some of the day 364 datasets (demographics, patient ID, etc) will be identical to what was submitted in the initial BLA for day 182, though other datasets will have changes, including changes to the safety related data (due to long term safety follow-up to day 364) and the inclusion of additional serology (MN) data that became available after day 182. GSK proposes to provide CBER with a table detailing differences between the datasets once a comparison is complete, targeting this week. After review of these differences by both GSK and CBER, GSK then proposes a discussion with CBER to agree upon a path forward.
Furthermore, GSK confirms that the SAS datasets submitted for Q-Pan -001, day 182 are correct and were submitted as planned.
I hope this helps clarify the situation for CBER. Again, we apologize for the mistake. Please let me know what can be done to help resolve the situation and if CBER concurs with the proposal suggested.
Michael P. Schwartz, PhD
U.S. Regulatory Affairs - Adjuvanted Influenza Vaccines