Csl 2009 influenza a h1n1 vaccine development plans
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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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CSL 2009 Influenza A (H1N1) VaccineDevelopment Plans

FDA, CBER, VRBPAC Meeting

July 23, 2009

Jillian Bennet, CSL Ltd

Proprietary For Official Use Only


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


CSL Biotherapies Influenza Vaccine (Afluria®)

  • US indications

  • CSL experience - 70 millions doses distributed

  • Licensed in 27 countries

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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)

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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

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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

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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

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CSL 2009 Influenza A (H1N1) Vaccine Clinical Trials

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CSL 2009 Influenza A (H1N1) Vaccine US Trials

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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

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CSL 2009 Influenza A (H1N1) Vaccine Clinical Trial Timelines

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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

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