Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection, version 1.0 dated 21 August 2017 Protocol A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-Child Transmission of Hepatitis B Virus Short title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis B infection Version 1.0 August 21 , 2017 Study Coordination Center: PHPT (Chiang Mai University - Institut de recherche pour Ie development Collaboration) 110 Intawaroros Rd. T. Sripoom, Muang OJ. Chiang Mai 50200 , Thailand ') , O! C:?.:' r '\ Telephone: +66 5381 9125 (up to 29) 2 1 ~ . O . ~ 2 r, 6 0 Fax: +66 53252253, +66 5381 9130 , I ..J E-mail: gon
[email protected] t) · :; m :i 1J n 1.j ~lV 1i H l1 f1l 1 1 ~tJ hnJ .lI ~ tJ (~ll ,rlH~~;.r"JlFn" ~" ...x-e- -, •.,- -j ~ ' r " ':C ' ~ " lJ ~ :" • .r-« I J "J ~ " " 'it}JrJ (lYflL , Study Title: Antiviral prophylaxis and infant vaccination to prevent perinatal hepatitis 8 infection, version 1.0 dated 21 August 2017 Table of Contents 1. Study Title 4 2. Protocol team and investigators' names and contact information .4 3. Project Summary 10 4. Background information 12 4.1 Background 12 4.2 Study Rationale 14 5. Study specific objectives 15 5.1 Study objectives 15 5.2 Study Design 16 6. Study sites and duration of the study 17 6.1 Study sites 17 6.2 Duration of the study 18 7. Workplan 19 7.1 Study population 19 7.1.1 Eligibility 19 7.1.2 Inclusion criteria 19 7.1.3 Exclusion criteria 19 7.1.4 Discontinuation criteria 19 7.2 Implementation, data collection, and monitoring procedures 20 7.2.1 Follow-up and study procedures 20 7.2.2 Laboratory assessments 22 7.2.3 Data collection 22 7.2.4 Reporting 22 7.2.5 Study implementation onsite monitoring 23 7.3 Study drugs 23 7.4 Biohazard Containment 23 7.5 Statistical considerations 23 7.5.1 Justifications for the design 23 7.5.2 Endpoints 23 7.5.3 Sample size 24 7.5.4 Analyses for the primary objective 25 7.5.5 Analyses for the secondary objectives/endpoints 25 7.6 Data and Safety Monitoring Board 26 8.