Meetings
Development of a Clinical Trial Plan for Pandemic Influenza Vaccines
September 22-23, 2003
Bethesda, MD
Introduction
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, WHO and representatives from Industry.
Objectives
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)
Presentations
Update on EU Regulatory Planning (PDF), Dr. John Wood, National Institute for Biological Standards and Control
Regulatory Considerations (PDF), Dr. Karen Midthun, Center for Biologics Evaluation and Research
Reagents for Influenza Pandemic Preparedness (PDF), Dr. Robert Webster, St. Jude Children's Research Hospital
Prospective Influenza Vaccines (PDF), Dr. John Wood and Representatives from the World Health Organization
Avian Influenza - Pandemic Preparedness (PDF), Dr. Nancy Cox, Centers for Disease Control and Prevention
Vaccine Experiences and Lessons Learned from the Past (PDF), Dr. Robert Couch, Baylor College of Medicine
Production of Influenza Vaccines from Reassortants Derived from Avian Influena Viruses: An Interim Biosafety Risk Assessment (PDF), Dr. John M Wood, Dr. Robert G Webster, Dr. Richard J Webby, Dr. James S Robertson, Dr. Jacqueline Katz, Dr. Roland A Levandowski, Dr. Gary Grohmann, Dr. Nancy Cox, Dr. Alan Hay, Dr. Masato Tashiro, Dr. Alan Hampson, Dr. Ian Gust, Dr. Klaus Stöhr
Recent Vaccine Experience with Novel Antigens (PDF), Dr. Karl Nicholson, University of Leicester
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