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VRBPAC Pentacel

VRBPAC Pentacel. Theresa Finn, Ph.D OVRR, CBER January 25, 2007. Pentacel (DTaP-IPV/Hib). DTaP-IPV used to reconstitute Hib (PRP-T) DTaP-IPV/Hib 2, 4, 6 and 15-18 months of age. VRBPAC. Safety Efficacy (Immunogenicity): D, T, polio: protective levels post-dose 3

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VRBPAC Pentacel

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  1. VRBPACPentacel Theresa Finn, Ph.D OVRR, CBER January 25, 2007

  2. Pentacel (DTaP-IPV/Hib) • DTaP-IPV used to reconstitute Hib (PRP-T) • DTaP-IPV/Hib • 2, 4, 6 and 15-18 months of age

  3. VRBPAC • Safety • Efficacy (Immunogenicity): • D, T, polio: protective levels post-dose 3 • Hib: protective levels and GMC post-dose 3 • Pertussis: • Serology bridge to DAPTACEL (DTaP) in Sweden I efficacy trial • Comparison to DAPTACEL (DTaP) in a U.S. study

  4. Questions and Discussion Items • Are the available data adequate to support the safety of four doses of Pentacel administered at 2, 4, 6 and 15-18 months of age? (Voting Item) If the available data are not adequate, what additional data are needed?

  5. Questions and Discussion Items cont’d. • 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?

  6. Questions and Discussion Items cont’d. 3. If Pentacel is licensed, please identify any issues which should be addressed in post-licensure studies.

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