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Sanofi Pasteur H1N1

Sanofi Pasteur H1N1 . VRBPAC 23July 2009. Clinical Development Plan. Urgent public health need Working closely with health authorities to provide a safe and effective vaccine as soon as possible Current study design considerations based on collaboration with FDA

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Sanofi Pasteur H1N1

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  1. Sanofi Pasteur H1N1 VRBPAC 23July 2009

  2. Clinical Development Plan • Urgent public health need • Working closely with health authorities to provide a safe and effective vaccine as soon as possible • Current study design considerations based on collaboration with FDA • Studying adjuvanted and non-adjuvanted formulations • Dose-ranging to assess immunogenicity and safety • One and two dose schedule • Pediatric and adult/elderly trials • Interim analysis after one dose in all age groups

  3. Clinical Development Plan Overview • Development Plan Objective • Obtain data to determine optimal formulation, dosage and schedule for vaccine production • Studies are sized to assess immunogenicity against FDA criteria • Evaluate safety • Development Plan Overview • Three clinical trials: two adult / elderly and one pediatric • Two types of vaccine candidates: non-adjuvanted and adjuvanted • 7.5, 15, 30 µg/dose for non-adjuvanted, 3.75 and 7.5 µg/dose for adjuvanted • Overall Database

  4. Current Clinical Timelines • Non-adjuvanted, adults / elderly and children • Study start = first week in August • D21 immunogenicity data = early October • D42 immunogenicity data = end October • Adjuvanted, adults / elderly • Study start = mid August • D21 immunogenicity data = end October • D42 immunogenicity data = mid November

  5. Manufacturing Considerations • Considerations impacting clinical timelines • Calibrated reagents not available to release clinical material • Needed for SRID • Formulation using HPLC allows clinical trial to begin first week in August vs. mid September • Other considerations • Low yield for H1N1 • Seasonal vaccine production, for Northern and Southern Hemispheres • Approval of additional filling lines

  6. Vaccine Availability • 4 Key decisions / requirements • Rapid FDA feedback to make formulation target decision (options) • Based on first available clinical data; October or subsequent data milestones • Public health authority request to formulate prior to clinical data availability • Approval of labeling and packaging components • CBER release strategy (specifications and process) • HHS task order for formulation, filling and packaging • Normal lead time for vaccine availability is approximately 6 weeks following these decisions / requirements

  7. Summary • Sanofi Pasteur is committed to responding rapidly to the urgent public health need • Large scale production initiated 22 June 2009 • Clinical trials begin early August with results as early as October • 4 critical decisions needed for availability of first doses • Best interest of public health • Working closely with WHO and HHS • Balancing both seasonal and A(H1N1) vaccine production

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