OBJECTIVES .................................................................................................. 14 2.1 Primary Objectives .............................................................................. 14 2.2 Secondary Objectives ......................................................................... 14 3. STUDY DESIGN ............................................................................................. 15 3.1 Description of the Study ...................................................................... 15 3.2 Rationale for Study Design .................................................................. 16 3.3 Outcome Measures ............................................................................. 16 3.3.1 Primary Outcome Measure .................................................. 16 3.3.2 Secondary Outcome Measures ............................................ 17 3.3.3 Ancillary Safety Outcome Measures .................................... 17 3.4 Safety Plan .......................................................................................... 17 3.4.1 Cardiac Dysfunction ............................................................. 17 3.4.2 Management of Cardiac Safety ............................................ 18 3.4.2.1 Adjuvant Breast Cancer Protocols ...................... 18 3.5 Dose Reductions of Vaccine Component ............................................ 21 3.6 Compliance with Laws and Regulations .............................................