VRBPAC Pentacel Theresa Finn, Ph.D OVRR, CBER January 25, 2007 Pentacel (DTaP-IPV/Hib) вЂў DTaP-IPV used to reconstitute Hib (PRP-T) вЂў DTaP-IPV/Hib вЂў 2, 4, 6 and 15-18 months of age VRBPAC вЂў Safety вЂў Efficacy (Immunogenicity): вЂ“ D, T, polio: protective levels post-dose 3 вЂ“ Hib: protective levels and GMC post-dose 3 вЂ“ Pertussis: вЂў Serology bridge to DAPTACEL (DTaP) in Sweden I efficacy trial вЂў Comparison to DAPTACEL (DTaP) in a U.S. study Questions and Discussion Items 1. Are the available data adequate to support the safety of four doses of Pentacel administered at 2, 4, 6 and 1518 months of age? (Voting Item) If the available data are not adequate, what additional data are needed? Questions and Discussion Items contвЂ™d. 2. Please discuss whether the available data are adequate to support the efficacy of: a) The diphtheria, tetanus and polio components of Pentacel, b) The Hib (PRP-T) component of Pentacel, and c) The pertussis component of Pentacel. Are the available data adequate to support the efficacy of Pentacel? (Voting Item) If the available data are not adequate, what additional data are needed? Questions and Discussion Items contвЂ™d. 3. If Pentacel is licensed, please identify any issues which should be addressed in post-licensure studies.