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A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-Administration of a Su

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A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-Administration of a Su Title: A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in Non-endemic Country for Dengue NCT Number: NCT03525119 Protocol Approve Date: 11 March 2019 Certain information within this protocol has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable information (PPD) or company confidential information (CCI). This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. TITLE PAGE PROTOCOL A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in Non-endemic Country(ies) for Dengue Immunogenicity and Safety of TDV Co-administered with a Hepatitis A Virus Vaccine Sponsor: Takeda Vaccines, Inc. 40 Landsdowne Street, Cambridge, MA 02139, USA Trial Identifier: DEN-314 IND Number: Not Applicable EudraCT Number: 2017-001071-23 Vaccine Name: Investigational vaccine: tetravalent dengue vaccine candidate (TDV) comprised of a molecularly characterized, attenuated dengue serotype 2 strain (TDV-2), a dengue serotypes 2/1 chimeric strain (TDV-1), a dengue serotypes 2/3 chimeric strain (TDV-3), and a dengue serotypes 2/4 chimeric strain (TDV-4) Licensed hepatitis A virus (inactivated) vaccine Placebo: Saline solution Date: 11 March 2019 Version: Version 5.0 (supersedes Version 4.0) Prope Takeda: For non-commercial use only and subject to the applicable Terms of Use 7DNHGD¶V7HWUDYDOHQW'HQJXH9DFFLQH&DQGLGDWH 7ULDO1R'(1 3DJHRI 3URWRFRO9HUVLRQ 0DUFK $'0,1,675$7,9(,1)250$7,21 &RQWDFWV 7DEOHD &RQWDFW,QIRUPDWLRQ T ,VVXH &RQWDFW b PPD 6HULRXVDGYHUVHHYHQWDQGSUHJQDQF\ UHSRUWLQJ )D[DQGWHOHSKRQHQXPEHUVIRUVHULRXVDGYHUVHHYHQWDQGDGYHUVH SUHJQDQF\UHSRUWLQJZLOOEHSURYLGHGWRWKHVLWHGWRWKHVGWRWK th 0HGLFDO0RQLWRU (PHUJHQF\PHGLFDOFRQWDFWLQIRUPDWLRQZLOOEHSURYLGHGWRIRUPDWLRQRUPDWL PHGLFDODGYLFHRQFRQGXFWRISURWRFRO WKHVLWH RUFRPSRXQG 5HVSRQVLEOH0HGLFDO2IILFHU (PHUJHQF\PHGLFDOFRQWDFWLFRQWDFWLRQWDFWLbjectbjeQIRUPDWLRQZLOOEHSURYLGHGWR to the ble Terms of Use FDUULHVRYHUDOOUHVSRQVLELOLW\IRUWKH WKHVLWH FRQGXFWRIWKHWULDO an Property of Takeda: For non-commercial use only and subje 7DNHGD¶V7HWUDYDOHQW'HQJXH9DFFLQH&DQGLGDWH 7ULDO1R'(1 3DJHRI 3URWRFRO9HUVLRQ 0DUFK $SSURYDO 5(35(6(17$7,9(62)7$.('$ 7KLVWULDOZLOOEHFRQGXFWHGZLWKWKHKLJKHVWUHVSHFWIRUWKHLQGLYLGXDOSDUWLFLSDQWVLQDFFRUGDQFHUGDQFHGDQFH ZLWKWKHUHTXLUHPHQWVRIWKLVFOLQLFDOVWXG\SURWRFRODQGDOVRLQDFFRUGDQFHZLWKWKHIROORZLQJORZLQJORZLQJ x 7KHHWKLFDOSULQFLSOHVWKDWKDYHWKHLURULJLQLQWKH'HFODUDWLRQRI+HOVLQNL x ,QWHUQDWLRQDO&RXQFLOIRU+DUPRQL]DWLRQRI7HFKQLFDO5HTXLUHPHQWVIRU3KDUPDFHXWLFDOVDUPDFHXUPDFH ( *RRG&OLQLFDO3UDFWLFH&RQVROLGDWHG*XLGHOLQH x $OODSSOLFDEOHODZVDQGUHJXODWLRQVLQFOXGLQJEXWQRWOLPLWHGWRWKRVHUHODWHGWRGDWDSULYDF\RVHUHODWHVHUHO DQGFOLQLFDOWULDOGLVFORVXUH 6,*1$785(6 t to the applicable Terms of Use PPD Property of Takeda: F Takeda’s Tetravalent Dengue Vaccine Candidate Trial No. DEN-314 Page 4 of 83 Protocol Version 5.0 11 March 2019 INVESTIGATOR AGREEMENT I confirm that I have read and that I understand this protocol, the Investigator’s Brochure, and any other product information provided by the Sponsor. I agree to conduct this trial in accordance with the requirements of this protocol and also protect the rights, safety, privacy, and well-being of trial subjects in accordance with the following: The ethical principles that have their origin in the Declaration of Helsinki. International Council for Harmonization of Technical Requirements for Pharmaceuticals, E6 Good Clinical Practice: Consolidated Guideline. All applicable laws and regulations, including, but not limited to those related to data privacy and clinical trial disclosure. Regulatory requirements for reporting serious adverse events defined in Section 10.4 of this protocol. Terms outlined in the Clinical Trial Site Agreement. Appendix A – Responsibilities of the Investigator. I further authorize that my personal information may be processed and transferred in accordance with the uses contemplated in Appendix B of this protocol. Signature of Investigator Date Investigator Name (print or type) Investigator’s Title Location of Facility (City, State) Location of Facility (Country) Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use Takeda’s Tetravalent Dengue Vaccine Candidate Trial No. DEN-314 Page 5 of 83 Protocol Version 5.0 11 March 2019 1.3 Protocol Amendment Summary of Changes This document describes the changes in reference to the Protocol incorporating Amendment No. 3. 1.3.1 Amendment History Date Amendment Number Amendment Type Region 30 May 2017 Initial Protocol Not applicable Global 27 December 2017 1 Substantial Global 17 September 2018 2 Non-substantial Global 11 March 2019 3 Non-substantial Global Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use 7DNHGD¶V7HWUDYDOHQW'HQJXH9DFFLQH&DQGLGDWH 7ULDO1R'(1 3DJHRI 3URWRFRO9HUVLRQ 0DUFK 6XPPDU\RI&KDQJHV $PHQGPHQWWR3URWRFRO9HUVLRQ6HSWHPEHU 5DWLRQDOHIRUWKH$PHQGPHQW er 7KLVSURWRFROKDVEHHQDPHQGHGWRXSGDWHWKHSURWRFROGHILQLWLRQRIµWULDOFRPSOHWLRQ¶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nd 6HFWLRQ 'HVFULSWLRQRIFKDQJH onlyon and subject to the applicable Terms of Use PPD PPD 2XWVLGHWKHFRQWH[WRIWKLVWULDOVXEMHFWVLQ*URXSVDQGZFRQWHRQW LOOEHRIIHUHGD+$9YDFFLQHERRVWHU GRVHDIWHUUWKHFRPSOHWLRQRIWULDOSURFHGXUHVDW'D\ 0RQWK>0@ WKHFRPWKHFR GDWDEDVHORFNDQG XQEOLQGLQJRIDOOWULDQGLQJRIGLQJRIn-c OGDWDLHDIWHUWULDOFRPSOHWLRQ /DVW6XEMHFW/DVW9LVLW 2XWVLGHWKHFRQWH[WRIWKLVWULDOVXEMHFWVLQ*URXSVDQGZXWVLGHWKHVLGHWKno LOOEHRIIHUHGD+$9YDFFLQHERRVWHU GRVHDIWHGRVHDGRVHDIWHUWKHFRPSOHWLRQRIWULDOSURFHGXUHVDW'D\ 0RQWK>0@ GDWDEDVHORFNDQG XQEOLQGLQJRIDOOWULDOGDWDLHEOL DIWHUWULDOFRPSOHWLRQ /DVW6XEMHFW/DVW9LVLW>/6/9@ a:2XWVLGHWKHFRQWH[WRIWKLVWULDOVXEMHFWVLQ*URXSVDQGZ2 LOOEHRIIHUHGD+$9YDFFLQHERRVWHU GRVHDIWHUWKHFRPSOHWLRQRIWULDOSURFHGXUHVDW'D\ 0RQWK>0@ GDWDEDVHORFNDQG XQEOLQGLQJRIDOOWULDOGDWDLHDIWHUWULDOFRPSOHWLRQ /6/9 Ta 7ULDOFRPSOHWLRQFRUUHVSRQGVWRWKHGDWHRQZKLFKWKHILQDOVXEMHFWZDVH[DPLQHGRUUHFHLYHGDQ LQWHUYHQWLRQIRUWKHSXUSRVHVRIILQDOFROOHFWLRQRIGDWDIRUWKHSULPDU\RXWFRPHZKHWKHUWKH FOLQLFDOWULDOFRQFOXGHGDFFRUGLQJWRWKHSUHVSHFLILHGSURWRFRORUZDVWHUPLQDWHG /6/9 ty Property of Takeda: For non-c Takeda’s Tetravalent Dengue Vaccine Candidate Trial No. DEN-314 Page 7 of 83 Protocol Version 5.0 11 March 2019 TABLE OF CONTENTS 1.0 ADMINISTRATIVE INFORMATION ..............................................................................2 1.1 Contacts..........................................................................................................................2 1.2 Approval ........................................................................................................................3 1.3 Protocol Amendment Summary of Changes..................................................................5 1.3.1 Amendment History .................................................................................................5 1.3.2 Summary of Changes ...............................................................................................6 2.0 TRIAL SUMMARY ..........................................................................................................12 2.1 Schedule of Trial Procedures .......................................................................................21 3.0 TRIAL REFERENCE INFORMATION ...........................................................................23 3.1 Trial-Related Responsibilities ......................................................................................23 3.2 Principal Investigator/Coordinating Investigator .........................................................23 3.3 List of Abbreviations ...................................................................................................24 3.4 Corporate Identification ...............................................................................................26 4.0 INTRODUCTION .............................................................................................................27 4.1 Background ..................................................................................................................27
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