Additional sites may be identified and held in reserve in the event that some of the original sites discontinue participation, or if enrollment is slower than expected. 14.12 Rationale and Changes 14.12.1 Rationale The main reason for this administrative amendment is to address feedback from the , who requested that the study protocol be updated to contain details regarding the Interim Analyses described in the Statistical Analysis Plan for this study. There is no impact to study design, conduct, or endpoints as a result of the language provided in Section 9.8, Interim Analyses. In addition, the sponsor address and medical monitor have been updated . 14.12.2 Changes General changes: • Update Sponsor Address and Medical Monitor name • Addition of Section 9.8, Interim Analyses and Section 14.12, Rationale and Changes • Updated Abbreviation list New text contained in the new Section 9.8, Interim Analyses is provided below An interim analysis plan (IAP) is included in the SAP for this study. Interim analyses are executed by a Contract Research Organization that acts as the independent statistician and assessed by the DMC as described in the DMC Charter. At each interim analysis, both unblinded (closed) and blinded (open) interim analysis rep orts will be provided to the DMC, while the sponsor will only receive an open (blinded) report unless one of the criteria is met. Even in this case , the DMC will use its discretion regarding the communications of results to the sponsor, with patient safety balanced against benefit being the primary concern. The IAP was designed to detect early evidence of both efficacy and futility. Interim analyse s for the two comparisons of overall survival described in Section 9.4 are to be executed at 40%, 60%, and 80% of information times, corresponding to 214, 321, and 427 deaths per comparison. The final analysis will be completed when 534 deaths per compari son have occurred. To maintain an overall one - sided type I error probability of 0.0125 per comparison, the one - sided significance criteria using one - sided O’Brien - Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 98 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Flemming boundaries for early detection of efficacy analyses are 0.000135, 0.00147, 0.00501, respectively, with the adjusted final analysis to use 0.01063. The significance level to be used for detection of futility at each interim analysis is 0.00001. This futility significance level was chosen in order to provide a balance between the sought for estimated probability of detecting futility and protecting against falsely detecting futility.