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Immunogenicity and Safety of a Tetravalent Dengue

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Immunogenicity and Safety of a Tetravalent Dengue Sanofi Pasteur CYD71CYD71 323 – CYD Dengue Vaccine Protocol Version 2.0 NCT Number: NCT02979535 Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico Phase IIIb, randomized, open-label, multicenter study in 480 female subjects aged 9 to 14 years in Mexico. Clinical Trial Protocol Amendment 1 Health Authority File Number(s): Not Applicable. WHO Universal Trial Number (UTN): U1111-1161-3455 Trial Code: CYD71 Development Phase: Phase IIIb Sponsor: Sanofi Pasteur 14, Espace Henry Vallée, F-69007 Lyon, France Investigational Product(s): CYD Dengue Vaccine Form / Route: Powder and solvent for suspension for injection/Subcutaneous Indication For This Study: Prevention of dengue fever in 9- to 14-year-old children Manufacturer: Same as Sponsor Coordinating Investigator This is a multi-center trial with multiple investigators. Investigators and study sites are listed in the “List of Investigators and Centers Involved in the Trial” document. Sponsor’s Responsible Medical Officer: Sanofi Pasteur Address: Tel: Project Manager and Study Leader: Address: 14, Espace Henry Vallée, F-69007 Lyon, France Tel: Fax: Country Medical Affair Address: Tel: Confidential/Proprietary Information Page Page 11 ofof 99100 Sanofi Pasteur CYD71CYD71 323 – CYD Dengue Vaccine Protocol Version 2.0 Product Safety Officer: , Sanofi Pasteur Tel: Email: Clinical Trial Manager: Address: Tel: ext Version and Date of the Protocol: Version 2.0 dated 05 February 2018 This protocol version 2.0 is the first amendment to the initial trial protocol version 1.0, dated 04 January 2016. Information contained in this publication is the property of Sanofi Pasteur and is confidential. This information may not be disclosed to third parties without written authorization from Sanofi Pasteur. This document may not be reproduced, stored in a retrieval system, or transmitted in any form or by any means–electronic, mechanical recording, or otherwise–without prior authorization from Sanofi Pasteur. This document must be returned to Sanofi Pasteur upon request. Confidential/Proprietary Information Page Page 22 ofof 99100 Sanofi Pasteur CYD71CYD71 323 – CYD Dengue Vaccine Protocol Version 2.0 Table 1: Previous versions of the protocol Version* Date Comments 1.0 04 January 2016 Original study protocol (first version used in the study) Amendment 1 * Versions in bold font have been approved by the Independent Ethics Committee(s) (IEC[s]) / Institutional Review Board(s) (IRB[s]) and used in the study. Confidential/Proprietary Information Page Page 33 ofof 99100 Sanofi Pasteur CYD71CYD71 323 – CYD Dengue Vaccine Protocol Version 2.0 Table of Contents List of Tables .................................................................................................................................... 9 Synopsis .......................................................................................................................................... 10 Table of Study Procedures ............................................................................................................ 22 List of Abbreviations ..................................................................................................................... 25 1 Introduction ..................................................................................................................... 28 1.1 Background ..................................................................................................................... 28 1.2 Background of the Investigational Product ..................................................................... 29 1.3 Potential Benefits and Risks ........................................................................................... 31 1.3.1 Potential Benefits to Subjects ....................................................................................... 31 1.3.2 Potential Risks to Subjects ........................................................................................... 32 1.4 Rationale for the Trial ..................................................................................................... 33 2 Trial Objectives ............................................................................................................... 36 2.1 Primary Objectives .......................................................................................................... 36 2.2 Secondary Objectives ...................................................................................................... 36 3 Investigators and Trial Organization ............................................................................ 37 4 Independent Ethics Committee / Institutional Review Board .................................... 37 5 Investigational Plan ......................................................................................................... 38 5.1 Description of the Overall Trial Design and Plan ........................................................... 38 5.1.1 Trial Design .................................................................................................................. 38 5.1.2 Justification of the Trial Design ................................................................................... 38 5.1.3 Trial Plan ...................................................................................................................... 38 5.1.4 Visit Procedures ............................................................................................................ 41 5.1.5 Planned Trial Calendar ................................................................................................. 47 5.1.6 Early Safety Data Review............................................................................................. 48 5.2 Enrollment and Retention of Trial Population ................................................................ 48 5.2.1 Recruitment Procedures ................................................................................................ 48 5.2.2 Informed Consent Procedures ...................................................................................... 48 5.2.3 Screening Criteria ......................................................................................................... 49 5.2.4 Inclusion Criteria .......................................................................................................... 49 5.2.5 Exclusion Criteria ......................................................................................................... 50 5.2.6 Medical History ............................................................................................................ 51 Confidential/Proprietary Information Page Page 44 ofof 99100 Sanofi Pasteur CYD71CYD71 323 – CYD Dengue Vaccine Protocol Version 2.0 5.2.7 Contraindications for Subsequent Vaccinations ........................................................... 52 5.2.7.1 Temporary Contraindications ..................................................................................... 52 5.2.7.2 Definitive Contraindications ...................................................................................... 52 5.2.8 Conditions for Withdrawal ........................................................................................... 52 5.2.9 Lost to Follow-up Procedures....................................................................................... 53 5.2.10 Classification of Subjects Who Discontinue the Trial.................................................. 53 5.2.11 Follow-up of Discontinuations ..................................................................................... 54 5.2.12 Follow-up and Reporting of Pregnancies ..................................................................... 54 5.3 Modification of the Trial and Protocol ........................................................................... 55 5.4 Interruption of the Trial .................................................................................................. 55 6 Vaccines Administered ................................................................................................... 55 6.1 Identity of the Investigational Products .......................................................................... 55 6.1.1 Identity of Trial Product 1: CYD Dengue Vaccine ...................................................... 55 6.1.1.1 Composition ............................................................................................................... 56 6.1.1.2 Preparation and Administration ................................................................................. 56 6.1.1.3 Dose Selection and Timing ........................................................................................ 57 6.1.2 Identity of Trial Product 2: Cervarix ............................................................................ 58 6.1.2.1 Composition ............................................................................................................... 58 6.1.2.2 Preparation and Administration ................................................................................. 58 6.1.2.3 Dose Selection and Timing ........................................................................................ 58 6.1.3 Identity of Control Product(s) ...................................................................................... 58 6.2 Identity of Other Product(s) ...........................................................................................
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