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Sanofi Pasteur's H1N1 Vaccine Clinical Development Plan: Ensuring Public Health

In response to the urgent public health need for an H1N1 vaccine, Sanofi Pasteur is collaborating closely with health authorities to provide a safe and effective vaccine as quickly as possible. The development plan includes rigorous clinical trials for both adjuvanted and non-adjuvanted formulations, aiming to establish optimal dosages and schedules for various age groups. Key milestones include interim analyses and immunogenicity data collection, with studies starting in early August 2009. The commitment to balancing seasonal and H1N1 vaccine production underscores the priority of public health.

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Sanofi Pasteur's H1N1 Vaccine Clinical Development Plan: Ensuring Public Health

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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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