Clinical Immunisation Research

This subject has the following teaching availabilities in 2009:

For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Student Support and Engagement Policy, academic requirements for this subject are articulated in the Subject Overview, Learning Outcomes, Assessment and Generic Skills sections of this entry.

It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this subject are encouraged to discuss this matter with a Faculty Student Adviser and Student Equity and Disability Support: http://services.unimelb.edu.au/disability

Topics covered include:

Recruitment strategies for immunisation studies
Population versus intervention studies
Ethics of conduct of studies in the developed and developing worlds
The informed consent process in immunisation
The role of control arms and where they are appropriate
Differences in immune responses with age
How to conduct vaccine studies including immunogenicity, efficacy, effectiveness and safety
Post marketing studies
Specific diseases will be used as examples. These will include meningococcal, rotavirus, influenza and pneumococcal

Two assignments, each of 2000 words, and each worth 50 per cent

This subject is not available as a breadth subject.

Students who successfully complete this subject will be able to:

Understand the basic principles of immunisation
Understand the methods employed in the conduct of immunisation clinical trials
Understand ethical issues specific to immunisation clinical trials
Understand how endpoints of immunisation clinical trials are determined, including surrogate markers
Define surrogate markers, and identify their limitations
Understand the immunological, microbiological and laboratory assessment of immunisation clinical trials
Understand principles of safety monitoring and post-licensure surveillance systems
Understand vaccine study design
Design a research proposal in immunisation