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Study Protocol Clinical Trial Protocol FY12-19, HP-12-19, POX-MVA-006 A randomized, open-label Phase III non-inferiority trial to compare indicators of efficacy for MVA-BN smallpox vaccine to ACAM2000 in 18-42 year old® healthy vaccinia naïve ®subjects Clinical Trial Protocol Edition 8 29 September 2016 NCT 01913353 Bavarian Nordic Page 1 of 1 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 FY12-19, HP-12-19, POX-MVA-006 A randomized, open-label Phase III non-inferiority trial to compare indicators of efficacy for MVA-BN smallpox vaccine to ACAM2000 in 18-42 year old® healthy vaccinia naïve ®subjects Clinical Trial Protocol Edition 8 29 September 2016 Bavarian Nordic Restricted Business Proprietary Page 1 of 208 Clinical Trial Protocol Doc. No. 92000007 FYI2-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-20 16 1 General Information 1.1 Principal Investigator Signature Page Herewith I agree that I have read and fully understand this protocol: A randomized, open-label Phase Ill non-inferiority trial to compare indicators of efficacy for MVA BN® smallpox vaccine to ACAM2000® in 18-42 year old healthy vaccinia-naiVe subjects This protocol describes all the information necessary to conduct the trial. I agree that I will conduct the trial according to the instructions given within this protocol. FUithermore, T agree that I will conduct this trial according to rnternational Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), the 2013 version ofthe Declaration ofHelsinki, the Belmont Report, as well as applicable local legal and regulatory requirements in the respective countries. I agree that all information revealed in this protocol is handled strictly confidentially. Additionally, I will permit trial related monitoring, audits, Institutional Review Board (IRB)/ Independent Ethics Committee (JEC) review and regulatory inspections, providing direct access to source data/documents. Principal Investigator (b) (1) (A) Bavarian Nordic Restricted Business Proprietary Page 2 of208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 1.2 Sponsor Signature Page By signing the protocol: A randomized, open-label Phase III non-inferiority trial to compare indicators of efficacy for MY A BN® smallpox vaccine to ACAM2000® in 18-42 year old healthy vaccinia-nai·ve subjects The undersigned parties agree that the protocol was written according to international ethical and scientific quality standards (ICH GCP), in compliance with the 2013 version of the Declaration of Helsinki, the Belmont Report, and applicable local legal and regulatory requirements in the respective countries. Coordinating Author Medical Monitor (b) (1) (A) Manager QC Development Biostatistician GCP/GYP Compliance Management Sr. VP Clinical Development Bavarian Nordic Restricted Business Proprietary Page 3 of208 C!inial Trial Plolocol Doc. No. 92000001 FY12·19. HP-12·19, POX-MVA-006 Editioi'IS 29-Scp-2016 1.2 Sponsor Sign• ture l'ngo By signiJlg lhe prQU)col: A randomized, opcn~labc:l Phase Ill non-inferiority trial to compare indicators ofeftkacy ror MVA BNCI smaJlpox vaccine ro ACAM2000'1 in 1842 year old haJlhy vaccinia-naive subjects The: undersigned parties aarcc lhA( lhe pt'O(OCOI was written .c:oonhn& 10 interrutional ethical and scicnlifle quality $lll1danls (ICII GCP), in compliance" ilb lbe 2013 vcnioo of the Dedlr.llion of l~rlsinki, the Belmont Report. and applicable k>caiJegal and rcgulalOry requin:ments in the respective countries.. Coordinating Aulllor Medical Monhor (b) (1) (A) ManagerQC Development Aios:tati.stician GCP{()VP Compliance Management Sr. VP Clinical Development Bavarian Nord'ic RC'Seriaed Business Plop • t 1 Page 3 or201 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 1.3 Responsibilities Trial Number FY12-19, HP-12-19, POX-MVA-006 Title A randomized, open-label Phase III non-inferiority trial to compare indicators of efficacy for MVA-BN® smallpox vaccine to ACAM2000® in 18-42 year old healthy vaccinia- naïve subjects. Principal Investigator (b) (1) (A) Phone (b) (1) (A) Fax E-mail (b) (1) (A) Sub-Investigator (b) (1) (A) Phone (b) (1) (A) E-mail (b) (1) (A) Sub-Investigator (b) (1) (A) Phone Bavarian Nordic Restricted Business Proprietary Page 4 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 E-mail (b) (1) (A) Clinical Trial Coordinator (b) (1) (A) Phone (b) (1) (A) E-mail (b) (1) (A) Clinical Trial Coordinator (b) (1) (A) Phone Email (b) (1) (A) Clinical Trial Coordinator (b) (1) (A) (b) (1) (A) Phone (b) (1) (A) Email (b) (1) (A) Bavarian Nordic Restricted Business Proprietary Page 5 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 Sponsor and Product Supply (b) (1) (A) MVA-BN® Phone (b) (1) (A) Fax Project Leader (b) (1) (A) Phone Fax (b) (1) (A) E-mail (b) (1) (A) Medical Monitor (b) (1) (A) Phone (b) (1) (A) Fax E-mail (b) (1) (A) Research Monitor (b) (1) (A) Phone E-mail (b) (1) (A) Bavarian Nordic Restricted Business Proprietary Page 6 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 Collaborator (b) (1) (A) Phone E-mail (b) (1) (A) Trial Statistician (b) (1) (A) (b) (1) (A) Phone Fax E-mail (b) (1) (A) CRO (b) (1) (A) (b) (1) (A) Phone Fax Bavarian Nordic Restricted Business Proprietary Page 7 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 Local Laboratory (Safety) (b) (1) (A) E-mail (b) (1) (A) Laboratory (Immunology (b) (1) (A) Assays) Phone (b) (1) (A) Fax E-mail (b) (1) (A) Centralized ECG (b) (1) (A) Assessment Phone (b) (1) (A) E-mail (b) (1) (A) Centralized Randomization (b) (1) (A) Phone E-mail (b) (1) (A) Bavarian Nordic Restricted Business Proprietary Page 8 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 Centralized Imaging of (b) (1) (A) ‘takes’ Phone (b) (1) (A) E-mail (b) (1) (A) DSMB Chair Member (b) (1) (A) (b) (1) (A) Phone E-mail (b) (1) (A) Independent Take Review (b) (1) (A) Committee (ITRC) Chair Member Phone Fax E-mail (b) (1) (A) Bavarian Nordic Restricted Business Proprietary Page 9 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 Table of Contents 1 General Information ........................................................................................ 2 1.1 Principal Investigator Signature Page ............................................................ 2 1.2 Sponsor Signature Page ................................................................................... 3 1.3 Responsibilities .................................................................................................. 4 Table of Contents .................................................................................................... 10 List of Tables ........................................................................................................... 16 List of Figures ......................................................................................................... 16 List of Abbreviations .............................................................................................. 17 Definitions ............................................................................................................... 20 1.4 Protocol Synopsis ............................................................................................ 22 1.5 Trial Procedure Schedule............................................................................... 32 2 Background Information and Scientific Rationale ..................................... 38 2.1 Introduction ..................................................................................................... 38 2.2 First Generation Smallpox Vaccines ............................................................. 38 2.3 Second Generation Smallpox Vaccines......................................................... 39 ® 2.4 Origin and Characteristics of MVA-BN ..................................................... 40 ® 2.5 Summary of Nonclinical Studies with MVA-BN ....................................... 41 ® 2.6 Clinical Profile of MVA-BN ......................................................................... 42 2.6.1 Safety Overview of MVA-BN® ................................................................... 42 2.6.2 Immunogenicity Overview of MVA-BN® .................................................. 49 2.7 Rationale .......................................................................................................... 50 2.8 Trial Population .............................................................................................. 52 2.9 Risk/Benefit Assessment ................................................................................. 53 2.9.1 Potential Risks ............................................................................................. 53 2.9.2 Benefits ......................................................................................................... 54 3 Objectives ........................................................................................................ 54 Bavarian Nordic Restricted Business Proprietary Page 10 of 208 Clinical Trial Protocol Doc. No. 92000007 FY12-19, HP-12-19, POX-MVA-006 Edition 8 29-Sep-2016 3.1 Co-Primary Objectives
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