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Study Protocol, GCP, Or Protocol-Specific MOP Requirements A Phase II Study in Healthy Adults 19 Years and Older to Assess the Safety, Reactogenicity and Immunogenicity of a Sanofi Pasteur A/H7N9 Inactivated Influenza Vaccine Administered Intramuscularly With or Without AS03 Adjuvant DMID Protocol Number: 17-0075 DMID Funding Mechanism: Vaccine and Treatment Evaluation Units Pharmaceutical Support: Sanofi Pasteur GlaxoSmithKline Biologicals IND Sponsor: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health Lead Principal Investigator: Lisa A. Jackson, MD, MPH DMID Clinical Project Manager: Robin M. Mason, MS DMID Medical Monitor: Mohamed Elsafy, MD DMID Medical Officer: Francisco J. Leyva MD, PhD, ScM DMID Scientific Lead: Chris Roberts, PhD Version: 5.0 3 April, 2019 DMID Protocol 17-0075 Version 5.0 Sanofi 2017 H7N9 with/without AS03 in Adults/Elderly April 3, 2019 STATEMENT OF COMPLIANCE This trial will be carried out in accordance with Good Clinical Practice (GCP) and as required by the following: • United States Code of Federal Regulations (CFR) 45 CFR Part 46: Protection of Human Subjects • Food and Drug Administration (FDA) Regulations, as applicable: 21 CFR Part 50 (Protection of Human Subjects), 21 CFR Part 54 (Financial Disclosure by Clinical Investigators), 21 CFR Part 56 (Institutional Review Boards), 21 CFR Part 11, and 21 CFR Part 312 (Investigational New Drug Application), 21 CFR 812 (Investigational Device Exemptions) • International Conference on Harmonisation: Good Clinical Practice (ICH E6); 62 Federal Register 25691 (1997); and future revisions • Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • National Institutes of Health (NIH) Office of Extramural Research, Research Involving Human Subjects, as applicable • National Institute of Allergy and Infectious Diseases (NIAID) Clinical Terms of Award, as applicable • Applicable Federal, State, and Local Regulations and Guidance i DMID Protocol 17-0075 Version 5.0 Sanofi 2017 H7N9 with/without AS03 in Adults/Elderly April 3, 2019 SIGNATURE PAGE The signature below provides the necessary assurance that this trial will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable US federal regulations and ICH E6 Good Clinical Practice (GCP) guidelines. I agree to conduct the study in compliance with GCP and applicable regulatory requirements. I agree to conduct the study in accordance with the current protocol and will not make changes to the protocol without obtaining the sponsor’s approval and IRB/IEC approval, except when necessary to protect the safety, rights, or welfare of subjects. Site Principal Investigator: Signed: Date: Name Title ii DMID Protocol 17-0075 Version 5.0 Sanofi 2017 H7N9 with/without AS03 in Adults/Elderly April 3, 2019 TABLE OF CONTENTS STATEMENT OF COMPLIANCE ................................................................................................. i SIGNATURE PAGE ...................................................................................................................... ii TABLE OF CONTENTS ............................................................................................................... iii LIST OF TABLES ........................................................................................................................ vii LIST OF FIGURES ..................................................................................................................... viii LIST OF ABBREVIATIONS ........................................................................................................ ix PROTOCOL SUMMARY ........................................................................................................... xiii 1 Key Roles ..............................................................................................................................22 2 Background Information and Scientific Rationale ...............................................................24 2.1 Background Information ...........................................................................................24 2.1.1 Public Readiness and Emergency Preparedness Act ....................................27 2.2 Scientific Rationale ...................................................................................................28 2.3 Potential Risks and Benefits .....................................................................................30 2.3.1 Potential Risks ..............................................................................................30 2.3.2 Known Potential Benefits .............................................................................37 3 Study Objectives and Outcome Measures ............................................................................38 3.1 Study Objectives .......................................................................................................38 3.1.1 Primary ..........................................................................................................38 3.1.2 Secondary ......................................................................................................38 3.1.3 Exploratory ...................................................................................................39 3.2 Study Outcome Measures .........................................................................................39 3.2.1 Primary ..........................................................................................................39 3.2.2 Secondary ......................................................................................................40 3.2.3 Exploratory ...................................................................................................41 4 Study Design .........................................................................................................................42 5 Study Enrollment and Withdrawal........................................................................................44 5.1 Eligibility Criteria .....................................................................................................44 5.1.1 Subject Inclusion Criteria .............................................................................44 5.1.2 Subject Exclusion Criteria ............................................................................45 5.2 Treatment Assignment Procedures ...........................................................................48 5.2.1 Enrollment and Randomization Procedures..................................................48 5.2.2 Masking Procedures ......................................................................................49 5.2.3 Reasons for Withdrawals and Discontinuation of Treatment .......................49 5.2.4 Handling of Withdrawals and Discontinuation of Treatment .......................51 5.2.5 Termination of Study ....................................................................................52 6 Study Intervention/Investigational Product ..........................................................................53 iii DMID Protocol 17-0075 Version 5.0 Sanofi 2017 H7N9 with/without AS03 in Adults/Elderly April 3, 2019 6.1 Study Product Description ........................................................................................53 6.1.1 Acquisition ....................................................................................................53 6.1.2 Formulation, Storage, Packaging, and Labeling ...........................................54 6.1.3 Study Product Storage and Stability Procedures ..........................................55 6.2 Dosage, Preparation, and Administration of Study Intervention/ Investigational Product ......................................................................................................................56 6.3 Modification of Study Intervention/Investigational Product for a Subject ...............57 6.4 Accountability Procedures for the Study Intervention/ Investigational Product ......58 6.5 Assessment of Subject Compliance with Study Intervention/ Investigational Product ...................................................................................................................................58 6.6 Concomitant Medications/Treatments ......................................................................59 7 Study Procedures and Evaluations ........................................................................................60 7.1 Clinical Evaluations ..................................................................................................60 7.2 Laboratory Evaluations .............................................................................................61 7.2.1 Clinical Laboratory Evaluations ...................................................................61 7.2.2 Special Assays or Procedures .......................................................................62 7.2.3 Specimen Preparation, Handling, and Shipping ...........................................64 7.2.3.1 Instructions for Specimen Preparation, Handling, and Storage ........64 7.2.3.2 Specimen Shipment ..........................................................................65 8 Study Schedule......................................................................................................................66
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