Study Endpoints 3.2.1. Primary Endpoint T he primary endpoint is overall survival (OS). OS is defined as the time between the date of randomization and the date of death due to any cause. Subjects who do not experience death or the competing events of “definite” loss to follow-up or withdrawal of consent will be right censored at the date of last contact. O S = Date of death/competing event/censoring - date of randomization + 1. Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 3 Revised: June 2015 3.2.2. Secondary Endpoint T he secondary efficacy endpoint for the study is the proportion of event- free subje cts (AWE) (radio graphic progression, pain progression, chemotherapy initiation, or death) at six months (or early termination) compared to placebo. P rogression events will be defined as: •Radiographic progression (per central radiology assessment) oTwo new lesions on bone scan, new metastases on CT scans*, or an increase size of nodal lesions per RECIST 1.1. •Pain progression** oIntroduction of scheduled opioid narcotics for cancer- related pain control. Scheduled opioid narcotics are defined as continuous daily use lasting more than14 days. •Initiation of chemotherapy for prostate cancer •Death * F or subject s with allergies to contrast agents, MRIs for abdomen and pelvis may be performed. Only in cases where MRI is unavailable may a non -contrast CT be perfor med. ** The start date for an event of pain progression is defined as day 1 of first opioid regimen lasting more than 14 days. R adiographic progression will be assessed by bone scan or CT at Screening, Week 13, Week 25 (EOT), and early termination scans. For secondary endpoint analysis, Screening scans and Week 13, Week 25 (EOT), and early termination scans will be compared by central radiology review. Bone scan and CT data will be archived up to five years past the end of the trial. T he secondary efficacy endpoint is a binary assessment for AWE at six months. Subjects without an event prior to six months will have an evaluation for event at six months. Subjects without event who are not evaluated at six months will be assumed to have had an event. Thus, e ach subject will be defined as AWE = 1 if the subject is alive and free of event at six months and AWE = 0 otherwise. AWE will have a realization for every subject and therefore is amendable to an intent- to-treat analysis. T he analysis of AWE is less subject to ascertainment anomalies compared to the analysis of time-to-progression because the six month assessment brings all subjects to the same level of ascertainment. 3.2.3. Exploratory Endpoint Th e exploratory efficacy endpoint for the study is the proportion of subjects Alive Without Event (AWE) (radio graphic progression, pain progression, chemotherapy initiation, or death) at the 6 month LTFU visit compared to placebo. For all subjects alive at the Week 25 (EOT) visit we will assess AWE at the 6 month LTFU visit . Subjects with pain progression or initiating Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 4 Revised: June 2015 chemotherapy for prostate cancer at the Week 25 (EOT) visit will be counted as having an event at the 6 month LTFU vis it. P rogression events at the 6 month LTFU visit will be defined as: •Radiographic progression (per central radiology assessment) taking the Week 25 (EOT) visit scan as baseline oTwo new lesions on bone scan, new metastases on CT scans*, or an increase si ze of nodal lesions per RECIST 1.1. •Pain progression** oIntroduction of scheduled opioid narcotics for cancer- related pain control. Scheduled opioid narcotics are defined as continuous daily use lasting more than14 days. •Initiation of chemotherapy for pr ostate cancer •Death * F or subject s with allergies to contrast agents, MRIs for abdomen and pelvis may be performed. Only in cases where MRI is unavailable may a non -contrast CT be performed. ** The start date for an event of pain progression is defined as day 1 of first opioid regimen lasting more than 14 days. T his will attempt to define effects on secondary progression, and characterize delayed effects of investigational vaccine therapy.