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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memo - June 26, 2009 - Hiberix




Date:  June 26, 2009

FDA STN:  125347

Sponsor:  GlaxoSmithKline

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.