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Study Protocol and Statistical Analysis Plan Official Protocol Title: A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy NCT number: NCT01254630 Document Date: 30-Jun-2015 Product: V212 Page 1 Protocol/Amendment No.: 011-04 THIS PROTOCOL AMENDMENT AND ALL OF THE INFORMATION RELATING TO IT ARE CONFIDENTIAL AND PROPRIETARY PROPERTY OF MERCK SHARP & DOHME CORP., A SUBSIDIARY OF MERCK & CO., INC., WHITEHOUSE STATION, NJ, U.S.A. SPONSOR: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck) One Merck Drive P.O. Box 100 Whitehouse Station, NJ, 08889-0100, U.S.A. Protocol-specific Sponsor Contact information can be found in the Administrative Binder. TITLE: A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy INVESTIGATOR: PRIMARY: CLINICAL PHASE: III US IND NUMBER: 13752 SITE: INSTITUTIONAL REVIEW BOARD/ETHICS REVIEW COMMITTEE: 30-Jun-2015 Confidential Product: V212 Page 2 Protocol/Amendment No.: 011-04 Table of Contents SUMMARY OF CHANGES...............................................................................................6 Primary Reason for This Amendment: ................................................................................6 Additional Changes for This Amendment:........................................................................10 1. SUMMARY.................................................................................................................11 1.1 TITLE ....................................................................................................................11 1.2 INDICATION........................................................................................................11 1.3 SUMMARY OF RATIONALE.............................................................................11 1.4 SUMMARY OF STUDY DESIGN ......................................................................13 1.5 SAMPLE ...............................................................................................................15 1.6 DOSAGE/DOSAGE FORM, ROUTE, AND DOSE REGIMEN.........................15 1.7 STUDY FLOW CHART .......................................................................................16 1.8 STUDY FLOW CHART FOR PATIENTS WITH SUSPECTED HZ .................19 2. CORE PROTOCOL.....................................................................................................21 2.1 OBJECTIVES AND HYPOTHESES ...................................................................21 2.1.1 Primary Objectives .........................................................................................21 2.1.2 Primary Hypotheses........................................................................................21 2.1.3 Secondary Objectives .....................................................................................21 2.1.4 Exploratory Objectives...................................................................................21 2.2 PATIENT INCLUSION CRITERIA.....................................................................22 2.3 PATIENT EXCLUSION CRITERIA....................................................................24 2.3.1 Deferment Criteria (Prior to Vaccination of Doses 2 through 4) ...................24 2.3.2 Continuation in the Study under Special Circumstances ...............................25 2.4 STUDY DESIGN AND DURATION...................................................................25 2.4.1 Summary of Study Design..............................................................................25 2.4.2 Vaccination Plan.............................................................................................29 2.5 LIST OF EFFICACY/IMMUNOGENICITY MEASUREMENTS......................30 2.5.1 HZ Case Determination..................................................................................30 2.5.2 Secondary Efficacy Measurements ................................................................32 2.5.3 Immunogenicity Measurements .....................................................................32 2.6 LIST OF SAFETY MEASUREMENTS...............................................................33 2.7 STATISTICAL ANALYSIS PLAN SUMMARY ................................................34 2.7.1 Efficacy...........................................................................................................34 2.7.2 Immunogenicity..............................................................................................35 2.7.3 Safety..............................................................................................................35 2.7.4 Power and Sample Size ..................................................................................36 2.7.5 Interim Analysis .............................................................................................37 3. PROTOCOL DETAILS...............................................................................................38 3.1 RATIONALE ........................................................................................................38 3.1.1 General Background.......................................................................................38 3.1.1.1 Epidemiology of HZ in Patients with HM..............................................39 Confidential Product: V212 Page 3 Protocol/Amendment No.: 011-04 3.1.1.2 Epidemiology of HZ in Patients with STM ............................................40 3.1.2 Rationale for This Study.................................................................................40 3.1.2.1 Rationale for Choice of Vaccine Inactivation Method ...........................42 3.1.2.2 Rationale for Dose Regimen...................................................................43 3.1.2.3 Rationale for Selection of Efficacy Endpoint Measures.........................45 3.1.2.4 Rationale for the Immunogenicity Endpoint Measures ..........................45 3.2 STUDY PROCEDURES.......................................................................................46 3.2.1 Visit Windows................................................................................................46 3.2.2 Informed Consent ...........................................................................................46 3.2.3 Assignment of Baseline Number....................................................................47 3.2.4 Non-Randomized Patients..............................................................................47 3.2.5 Study Participation Patient Identification Card..............................................47 3.2.6 Physical Examination .....................................................................................47 3.2.7 Medical History/Conditions ...........................................................................47 3.2.8 History of Varicella-Zoster Virus Infection ...................................................48 3.2.9 Concomitant Medication(s)/Treatment(s) ......................................................48 3.2.10 Contraception .................................................................................................49 3.2.11 Pregnancy Testing ..........................................................................................50 3.2.12 Stratification/Randomization/Allocation........................................................50 3.2.13 Blood Collection for Immunoassays ..............................................................51 3.2.14 Vaccination.....................................................................................................51 3.2.14.1 Dosage and Administration.....................................................................52 3.2.14.2 General Precautions for Administration .................................................52 3.2.14.3 Preparation of the Vaccine......................................................................52 3.2.14.4 Administration of the Study Vaccine......................................................53 3.2.14.5 Replacement Vials ..................................................................................53 3.2.15 Clinical follow-up for safety ..........................................................................53 3.2.16 Exposure Survey.............................................................................................53 3.2.17 Follow-up of Suspected HZ Cases .................................................................54 3.2.17.1 Definition of a Suspected Case of HZ ....................................................54 3.2.17.2 Identification of Suspected HZ Cases.....................................................54 3.2.17.3 Suspected HZ Case Follow-Up (Cases With HZ and HZ-like Rash) .......................................................................................................55 3.2.17.4 Suspected HZ Case Follow-Up (Cases Without HZ/HZ-like Rash) .......................................................................................................58 3.2.17.5 Treatment of HZ in Study Patients .........................................................59 3.2.18 Blinding/Unblinding.......................................................................................60 3.2.19 Study Completion Procedures ........................................................................60 3.2.20 Discontinuation/Withdrawal from Study .......................................................61
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