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Development of a Clinical Trial Plan for Pandemic Influenza Vaccines

September 22-23, 2003
Bethesda, Maryland


As part of its contribution to influenza pandemic preparedness and response, the National Institute of Allergy and Infectious Diseases sponsored a workshop “Development of a Clinical Trial Plan for Pandemic Influenza Vaccines” on September 22-23, 2003 in Bethesda, Maryland. Participants attending this workshop included individuals from HHS, FDA, CDC, USDA, and WHO and representatives from Industry.


The goal of this meeting was to frame a research plan for the development and clinical evaluation of pandemic influenza vaccines. The primary objectives of this workshop were to

  • Review clinical studies that have previously been conducted with vaccines made from influenza viruses with pandemic potential.
  • Identify manufacturing and regulatory issues related to the production and clinical evaluation of pandemic influenza vaccines.
  • Identify influenza strains and reagents that need to be produced and identify opportunities for international collaboration.
  • Determine the types of vaccine studies that need to be conducted now during the interpandemic period to build a scientific base of knowledge.
  • Identify points to consider for the design of a clinical protocol that can be used to evaluate a pandemic vaccine.

Meeting Agenda (PDF)

Meeting Participants (PDF)

Meeting Summary (PDF)​

Last Updated October 13, 2008