DEPARTMENT OF HEALTH & HUMAN SERVICES
|DATE:||July 9, 2009|
|TIME:||10:40 am, eastern standard time|
|SUBJECT:||Hiberix BLA STN 125347 Package insert—Request for clarification regarding sponsor’s response to July 8, 2009 telecon|
|PRODUCT:||Hiberix SPONSOR: GlaxoSmithKline (GSK)|
|CBER Participants:||Karen Farizo|
|GSK Participants:||Elisa Harkins|
In a July 8, 2009 telecon, CBER requested clarification on Lines 93 and 94 of the Hiberix draft annotated package insert sent by GSK via Email on July 8, 2009. In their response to this telecon question, in a July 9, 2009 Email, GSK stated the following:
The label states:
“In 7 clinical studies, 1,008 children received Hiberix as a booster dose following primary vaccination with either Hiberix (N= 530), Haemophilus b Conjugate Vaccine manufactured by Sanofi Pasteur SA (N = 235), Haemophilus b Conjugate Vaccine manufactured by Merck & Co., Inc. (N = 26), or Haemophilus b Conjugate Vaccine manufactured by Wyeth Pharmaceuticals Inc. (no longer licensed in the US, N = 217)”
CBER initiated a telecon on July 9, 2009 because in GSK’s response, the package insert is mis-quoted. Specifically, the draft package insert states that 234 (not 235) children received Sanofi Pasteur’s vaccine and 27 (not 26) children received Merck’s vaccine.
GSK acknowledged that the numbers used by CBER (235 Sanofi Pasteur’s vaccine and 26 Merck’s vaccine) in their June 26, 2009 comments on the package insert were correct and that these numbers were incorrectly changed by GSK in the package insert sent by Email on July 8, 2009. GSK indicated that they would correct the numbers in the next version of the package insert.