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CSL 2009 Influenza A (H1N1) Vaccine Development Plans

CSL 2009 Influenza A (H1N1) Vaccine Development Plans. FDA, CBER, VRBPAC Meeting July 23, 2009 Jillian Bennet, CSL Ltd . Overview of presentation. CSL Biotherapies US licensed seasonal vaccine Afluria ® Plans for novel H1N1 manufacture and supply Clinical trial program Design Status.

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CSL 2009 Influenza A (H1N1) Vaccine Development Plans

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  1. CSL 2009 Influenza A (H1N1) VaccineDevelopment Plans FDA, CBER, VRBPAC Meeting July 23, 2009 Jillian Bennet, CSL Ltd Proprietary For Official Use Only

  2. Overview of presentation • CSL Biotherapies US licensed seasonal vaccine • Afluria® • Plans for novel H1N1 manufacture and supply • Clinical trial program • Design • Status Proprietary For Official Use Only

  3. CSL Biotherapies Influenza Vaccine (Afluria®) • US indications • CSL experience - 70 millions doses distributed • Licensed in 27 countries Proprietary For Official Use Only

  4. Afluria® Manufacturing Overview Split virion, inactivated vaccine • Presentations licensed • Thimerosal-free PFS • Multidose vial • Manufacture • Antigen manufacture Australia for NH & SH • Fill & finish • Australia • Germany • USA (pending FDA approval) Proprietary For Official Use Only

  5. Afluria® &H1N1 2009 Current Status • Seasonal TIV Status • On track to meet US forecast commitments • A/California/7/2009 (H1N1) • Strain X-179A • Manufacture commenced June 09 Proprietary For Official Use Only

  6. CSL Influenza Vaccine Planning Calendar 2009 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Antigen Northern Hemisphere H1N1 SH Production Vaccine Formulation Proprietary For Official Use Only

  7. CSL 2009 Influenza A (H1N1) Clinical Trials Two clinical programs • Australia & US - complementary, overlapping • US Program • Execute under BARDA, HHS Contract • IND filed with FDA • Thimerosal-free formulation for pediatric trials Proprietary For Official Use Only

  8. CSL 2009 Influenza A (H1N1) Vaccine Clinical Trials Proprietary For Official Use Only

  9. CSL 2009 Influenza A (H1N1) Vaccine US Trials Proprietary For Official Use Only

  10. CSL 2009 Influenza A (H1N1) Vaccine Trial Endpoints • Immunogenicity • HI response post-dose 1 & 2 • Seroconversion • Seroprotection rate > 1:40 • Safety • 21 days post-dose 1 & 2 • Monthly assessments to 6 months • Facilitate timely safety signal detection • (SAEs, AESI, deaths, new onset chronic illness) • Interim review of immunogenicity and safety data after dose 1 & 2 Proprietary For Official Use Only

  11. CSL 2009 Influenza A (H1N1) Vaccine Clinical Trial Timelines Proprietary For Official Use Only

  12. Summary - CSL 2009 Influenza A (H1N1) Vaccine • CSL Biotherapies has commenced manufacture of antigen • Clinical trials have commenced in Australia • Initial data will be shared with FDA in September • IND filed with FDA • US clinical trials will commence in mid-August • Vaccine will be thimerosal-free in pediatric trials • Vaccine will be supplied to NIAID for additional trials Proprietary For Official Use Only

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