DEPARTMENT OF HEALTH & HUMAN SERVICES
DATE: July 16, 2009
TIME: 4:15 pm, eastern standard time
SUBJECT: Hiberix BLA STN 125347—Package Insert
SPONSOR: GlaxoSmithKline (GSK)
CBER Participants: Karen Farizo
GSK Participants: Elisa Harkins
GSK initiated the call to request clarification on the Indications and Usage Section of the Hiberix package insert. Currently, the package insert states: “HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization.” GSK inquired whether it would be acceptable to include language that would permit use of HIBERIX in children 15 months through 4 years of age who had not yet completed the primary series with another vaccine (including children who were “partially primed”). CBER indicated that the approval was for booster immunization only, not primary immunization, and that no data had been submitted on use of HIBERIX in children who were “partially primed”. CBER advised GSK that they could submit any proposal for changes to the Indications and Usage Section of the package insert to the BLA. GSK indicated that they did not anticipate doing so, but wanted clarification from CBER to pre-empt questions about usage of HIBERIX.