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Clinical Trial Protocol PROTOCOL Dok.#: 129K-PMS-MR Page 1 of 55 Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children Phase IV PMS-MR-0417 CLINICAL TRIAL PROTOCOL Sponsor PT BIO FARMA (PERSERO) Jl. Pasteur No. 28 Bandung – 40161 Indonesia August 2017 The information contained in this document is the property of Bio Farma and is confidential. It may be submitted to a Regulatory Authority, an Institutional Review Board/Ethics Committee, or an Investigator or a Pharmacist for the purpose of assessment in relation to registration of the product or initiation of a clinical trial. Reproduction or disclosure of the information in whole or in part is forbidden without the written consent of Bio Farma. This document must be returned to Bio Farma Versionupon request. 1.0 August 2017 PT Bio Farma PROTOCOL Dok.#: 129K-PMS-MR Page 2 of 55 Reactogenicity and Protectivity Following Measles-Rubella (MR) Routine Immunization in Indonesian Infants and Children PMS-MR-0417 CLINICAL TRIAL PHASE IV (POST MARKETING SURVEILLANCE) Sponsor PT. BIO FARMA (PERSERO) Jl. Pasteur No. 28 Bandung – 40161 INDONESIA Investigational Product Measles-Rubella (MR) Vaccine Manufacturing Sites Serum Institute of India PVT.LTD. 212/2, Hadapsar, Pune 411028, India Principal Investigator Dr. dr. Dominicus Husada, SpA(K) Sub-Investigators dr. Dwiyanti Puspitasari, SpA(K) dr. Leny Kartina, SpA(K) Medical Advisor Prof. Dr.dr. Ismoedijanto, SpA(K) Prof. dr. Parwati S. Basuki, SpA(K) Biometry Dr. dr. Windhu Purnomo, MS Monitors Dr. Novilia Sjafri Bachtiar, dr., M.Kes. Rini Mulia Sari, dr. Julianita Fahmi, dr. Asep Irham Fattahul Qur'an, dr Biological Laboratory Rini Mulia Sari, dr. Yani Sukriyani Lestari Version Number 1.0 Date August 2017 Version 1.0 August 2017 PT Bio Farma PROTOCOL Dok.#: 129K-PMS-MR Page 3 of 55 Table of Contents Table of Contents ........................................................................................................... 3 SYNOPSIS ..................................................................................................................... 6 FLOW CHART .............................................................................................................. 9 ABBREVIATIONS AND SYMBOLS USED ............................................................. 11 GLOSSARY ................................................................................................................. 12 1. BACKGROUND AND RATIONALE ................................................................. 14 1.1 Introduction ................................................................................................... 14 1.2 Epidemiology ................................................................................................ 15 1.3 Prevention and Control of Infection among Humans .................................... 17 1.4 Rationale ........................................................................................................ 17 1.5 Previous MR Vaccine (SII) Study ................................................................. 18 2. OBJECTIVES ....................................................................................................... 22 2.1 Primary Objective .......................................................................................... 22 3. TRIAL DESIGN AND METHODOLOGY ......................................................... 23 3.1 Trial Design ................................................................................................... 23 3.1.1 Treatment Allocation Procedures ........................................................... 23 3.2 Trial Population .................................................................................................. 23 3.1.2 Inclusion Criteria .................................................................................... 23 3.2.2 Exclusion Criteria for Infants: ..................................................................... 24 3.3 Ethical Considerations/Protocol Review ............................................................ 24 3.3.1 Protocol Review ........................................................................................... 24 3.3.2 Ethical Considerations ................................................................................. 24 3.4 Trial Calender/Timelines .................................................................................... 25 3.5 Trial Centres ....................................................................................................... 25 3.6 Vaccination and Serology Schedule .................................................................. 25 3.7. Case Report Form and Data Collection ............................................................. 26 3.8 Subject Diaries and Interim Histories ................................................................. 26 3.9. Procedure for Obtaining, Handling of Serum Samples (Sub Study) ................. 26 3.9.1 Obtaining Serum Samples............................................................................ 26 Version 1.0 August 2017 PT Bio Farma PROTOCOL Dok.#: 129K-PMS-MR Page 4 of 55 3.9.2 Handling Serum Samples ............................................................................. 27 3.9.3 Blinding Procedure ...................................................................................... 28 3.10 Clinical Supplies ............................................................................................... 28 4. PRODUCTS .......................................................................................................... 29 4.1 Investigational Product Characteristics: Measles/Rubella vaccine (Serum Institute of India) ...................................................................................................... 29 4.1.1 Product Description ..................................................................................... 29 4.1.2 Composition ................................................................................................. 29 4.1.3 Preparation ................................................................................................... 29 4.2 Precautions for use ............................................................................................. 29 4.3. Labeling and Packaging .................................................................................... 29 4.4. Storage and Shipment Conditions ..................................................................... 30 4.4.1. Shipment Conditions ................................................................................... 30 4.5.2 Storage Conditions ....................................................................................... 30 5. TRIAL ADMINISTRATION ............................................................................... 31 5.1 Personnel Involved in the Trial ..................................................................... 31 5.2. Visit Procedures ................................................................................................. 31 5.3 Lost to Follow-up Procedures ....................................................................... 32 5.4 Termination Classification ............................................................................ 32 5.5 Monitoring, Auditing, and Archiving ............................................................ 33 5.5 1 Routine Monitoring ...................................................................................... 33 5.5.2 Audits and Inspections ................................................................................. 34 5.5.3 Archiving ..................................................................................................... 34 6. ADVERSE EVENT REPORTING....................................................................... 35 6.1 Definitions ..................................................................................................... 35 6.2 Expected Reactions........................................................................................ 36 6.3 Safety Data Collection and Management Procedures ................................... 36 6.4 Reporting of Serious Adverse Events ........................................................... 38 6.5 Causality Assessment ......................................................................................... 38 7. EVALUATION CRITERIA ................................................................................. 42 7.1 Primary Evaluation Criteria ........................................................................... 42 7.1.1 Definitions of the Criteria ...................................................................... 42 7.1.2 Parameters to be Measured .................................................................... 42 Version 1.0 August 2017 PT Bio Farma PROTOCOL Dok.#: 129K-PMS-MR Page 5 of 55 7.2 Secondary Evaluation Criteria ....................................................................... 42 7.2.1 Definition of the Criteria ........................................................................ 42 7.2.2 Parameters to be Measured .................................................................... 43 7.2.3 Method and Timing of Measurement ..................................................... 43 8. BIOMETRY .......................................................................................................... 44 8.1 Statistical Methods and Data Analysis .........................................................
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