Vaccine Trials: Methods and Best Practices

This course will cover the following topics: A brief review of vaccine history and types; how vaccine trials are conducted, including which data are collected and how those data are managed and evaluated; appropriate processes to ensure human subjects protection and informed consent; methods for recruitment and enrollment of participants; and vaccine safety assessment. Upon successfully completing this course, students will be able to:

• Describe the types of vaccines in use today
• Describe how vaccines are evaluated in phase I and II clinical trials
• Identify key regulatory requirements, considerations and ethical standards for human subjects protection and informed consent. 
• Discuss how clinical trials are conducted with an emphasis on quality data and protection of the rights, safety and well-being of volunteers.