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Final Version 1.0. Clinical Study Protocol 09-Aug- 2017 Administrative Change Final Version 1.0. Clinical Study Protocol 09-Aug- 2017 Administrative change A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants Product IPV and f-IPV Protocol Number IPV-004 ABMG ClinicalTrials.gov Number NCT03239496 Clinical Phase Phase 3 Clinical Indication Injectable Polio Vaccine immunization Version Final 1.0 Issue Date 09-Aug-2017 Date of the administrative 12-Apr-2018 change Sponsor FIDEC – Fighting Infectious Diseases in Emerging Countries 2050 Coral Way, Suite 407 Miami, FL 33145 USA Sponsor Representative Ricardo Rüttimann, MD Tel + 1 305 854 0075, Fax + 1 305 856 7847 Confidential Page 1 Final Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug-2017 Administrative change SIGNATURES Signature of Sponsor Representative Title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants Name: Ricardo Rüttimann, MD Tel + 1 305 854 0075, Fax + 1 305 856 7847 This Clinical Study Protocol and Amendments (if any) have been reviewed and approved by the Sponsor in order to ensure compliance with Good Clinical Practice. Signature: Date: CONFIDENTIAL 2 Final Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug-2017 Administrative change Signature of Statistician Title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Doses of Inactivated Polio Vaccine in Latin American Infants Name: Chris Gast Affiliation: Gast Statistical Consulting, LLC Address: Woodinville, WA, USA This Clinical Study Protocol and Amendments (if any) have been reviewed and approved by the study statistician in order to ensure that the protocol and any amendments cover all relevant statistical matters clearly and accurately, using technical terminology as appropriate. Signature: Date: CONFIDENTIAL 3 Final Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug-2017 Administrative change Signature of Investigator Title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Doses of Inactivated Polio Vaccine in Latin American Infants Name: Luis Rivera, MD Affiliation: Hospital Maternidad Nuestra Señora de la Altagracia Address: Calle Pedro Henríquez Ureña #49, Santo Domingo, Dominican Republic I have read this Clinical Study Protocol and Amendments (if any) and agree that it contains all information necessary for the proper conduct of the study. I will carry out the study as outlined herein, will complete the study within the designated time and in accordance with Good Clinical Practice. Signature: Date: CONFIDENTIAL 4 Final Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug-2017 Administrative change Signature of Investigator Title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Doses of Inactivated Polio Vaccine in Latin American Infants Name: Xavier Sáez-Llorens, MD Affiliation: Cevaxin, Address: Panama City and Chiriquí, Republic of Panama I have read this Clinical Study Protocol and Amendments (if any) and agree that it contains all information necessary for the proper conduct of the study. I will carry out the study as outlined herein, will complete the study within the designated time and in accordance with Good Clinical Practice. Signature: Date: CONFIDENTIAL 5 Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug- 2017 Administrative change PROTOCOL HISTORY Protocol History FIDEC Document Issue Date Amendment Type Comments/Rationale for the changes Final version 1.0 09-August-2017 -NA Final version with administrative 09-April-2018 Administrative change changes Section 6.3, Other medications administered in the study, Page 32 “All details from The statement that concomitant medications will be recorded in the CRF concomitants vaccines was deleted, since the study centers will use specific forms for this. administered will be recorded in the corresponding forms. Only medications to treat SAEs, IMEs and severe local reactions will be documented in the corresponding forms” Administrative change Section 7 Prior and concomitant therapy, Page 35 “Infants in Panama will As per study centers request, it is clarified that participants in Panama will receive 2 doses of influenza at receive other vaccines part of the EPI. 6 and 7 months old, according to the National Immunization Schedule. This procedure will not be part of the study visits.” Administrative change Section 8.1 Table 2 Time and CONFIDENTIAL 6 Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug- 2017 Administrative change Event Schedule, page 36 and 37 - “Serious Adverse (SAEs), For greater clarity at study centers, the moment in which SAEs and IMEs Important Medical Events must be reported is specified, as well as the week until they will be (IMEs) and severe local reported reactions: To be reported and followed up at any moment throughout the study, upon signature of the Informed Consent until the week 40. - + Concomitant vaccines at As per study centers request, it is clarified that participants in Panama will weeks 6 and 14 are receive other vaccines part of the EPI. Pneumococcal Rotavirus and DTPw-HB-Hib and at week 10 only DTPw-HB-Hib. Infants in Panama will receive 2 doses of influenza at 6 and 7 months old, according to the National Immunization Schedule. This procedure will not be part of the study visits. - µ Measurement will be The photo was added to document the measurements performed with a standard millimeter ruler and will include 2 photos to be taken: 1 at 0 minutes, and a second photo at 30 minutes after vaccination. - The period between For greater clarity at study centers, the minimum period between visits and vaccination visits will be of at samples collection is specified least 28 days. The period between visits for blood CONFIDENTIAL 7 Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug- 2017 Administrative change collection will be of at least 28 days.” Administrative change Section 8.1.1 Collection and handling of blood samples, page 37 “A total of four vein or For greater clarity at study centers, details of the blood sample are added: arterial blood samples will be vein or arterial blood, and information about the location of the puncture, collected from each infant, depending on the subjects. prior to vaccination and according to their scheduled visits. Blood will be collected using butterfly needle or hypodermic needles and syringe. The location of the puncture will vary, depending on the subject” Administrative change Section 11.1.1 Serious Adverse Events Page 46 “The Investigator(s) will be For greater clarity at study centers, the moment in which SAEs must be responsible for recording and reported is specified reporting within 24 hours and according to regulatory timelines all SAEs observed during the study period (upon signature of the Informed Consent)” Administrative change Section 11.1.2 Important Medical Event Page 46 CONFIDENTIAL 8 Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug- 2017 Administrative change “The Investigator(s) will be For greater clarity at study centers, the moment in which IMEs must be responsible for recording and reported is specified reporting within 24 hours and according to regulatory timelines all IMEs observed during the study period (upon signature of the Informed Consent)” Administrative change Section 11.6 Reporting of serious adverse events and important medical events to the sponsor, page 48 “The form will be sent Information about SAE and IME form encrypting and the means to send encrypted, and the password the report via email, instead of fax, is added, as well as information about to open it will be sent in a the password to open the document separate email. The SAE form should include Concomitant medications is added to the SAEs narrative a clearly written narrative describing signs, symptoms, and treatment of the event, diagnostic procedures, concomitant medication, as well as any relevant laboratory data” Administrative change Section 11.7 Reporting of Serious Adverse Events to Competent Authority/Ethics Committees Page 49 CONFIDENTIAL 9 Version 1.0- CLINICAL STUDY PROTOCOL 09-Aug- 2017 Administrative change “The investigators assume The responsible for reporting adverse events before authorities is clarified responsibility for appropriate It is specified that the report is of SAEs reporting of SAEs to the In Uruguay is deleted since it was an error regulatory authorities- The investigators will also report all SAEs…” Administrative change Section 13.3 Source Documentation Page 54 “At a minimum, source Concomitant medications is eliminated since they will not be recorded on documentation must be the eCRF, but on specific forms in the event of SAEs, IMEs and severe available to confirm the local reactions. following data collected in the eCRF: subject identification, eligibility, and study identification; study discussion and date of informed consent, dates of visits, results of safety and immunogenicity parameters as required by the protocol, record of all AEs, follow-up of AEs,” CONFIDENTIAL 10 Final Version 1.0- CLINICAL STUDY PROTOCOL 09- Aug- 2017 Administrative change TABLE OF CONTENTS Title Page ..........................................................................................................................
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