Date: June 26, 2009
FDA STN: 125347
Product: Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)[Proposed
proprietary name: Hiberix]
Indication: Active immunization as a booster dose for the prevention of invasive disease caused by
Haemophilus influenzae tybe b (Hib) in children 15 months through 4 years of age (prior
to 5th birthday).
To: BLA File 125347
From: David Menschik
Medical Officer, Vaccine Safety Branch, Division of Epidemiology
Through: Andrea Sutherland,
Acting Chief, Vaccine Safety Branch
Robert P. Wise
Deputy Director, Division of Epidemiology
This memo acknowledges that the sponsor has adequately addressed the comments in the March 27, 2009 pharmacovigilance plan review memo.