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Vaccine Think Tank

Symposium Series on Vaccine Solutions for Developing Countries

A Report of HAI

October 20-23, 1996
Boston, Massachusetts, USA

Sponsor
Fogarty International Center
International AIDS Vaccine Initiative
Merck & Co., Inc.
Albert B. Sabin Vaccine Foundation
Until There’s a Cure Foundation

“HIV Vaccines for Developing Countries: Designing Efficacy Trials” was sponsored by HAI, with generous support from the Fogarty International Center of the National Institutes of Health; the International AIDS Vaccine Initiative; Merck & Co., Inc.; the Albert B. Sabin Vaccine Foundation; and the Until There’s a Cure Foundation.

The report was produced by HAI.

TABLE OF CONTENTS

Introduction
Basic Considerations for Vaccine Design
Justification for Launching Phase III Trials of Candidate Vaccines
Randomization, Sample Size, and Duration
The Impact of Behavior on Extrapolation of Results
Additional Design and Analysis Issues
Ethical and Regulatory Challenges
Agency Perspectives
Conclusion
Appendix: Symposium Participants

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