protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT03343626 | 4.2.2 | BARDA Funding Award | 4.2.2 BARDA Funding Award The Biomedical Advanced Research and Development Authority (BARDA) from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response is providing funding to Takeda for the US-based PIZV development program (82). es' | [] |
NCT03343626 | 4.2.3 | Vaccines Under Development | 4.2.3 Vaccines Under Development Currently, there is no approved vaccine against ZIKV. Various companies and academic organizations are using a variety of vaccine approaches, including inactivated virus, virus-like particles, nucleic-acid-based vaccines, live vectored vaccines, subunit vaccines, and live recombinant ap... | [] |
NCT03343626 | 4.2.4 | Summary of Available Non-clinical Data | 4.2.4 Summary of Available Non-clinical Data There are no non-clinical data currently available for PIZV. PIZV will be tested for nonclinical safety in a 3-dose Good Laboratory Practice-compliant, repeat-dose toxicity and local tolerance study in New Zealand White Rabbits. Toxicology data will be available prior to stu... | [] |
NCT03343626 | 4.2.5 | Summary of Available Clinical Data | 4.2.5 Summary of Available Clinical Data There are no clinical data currently available for PIZV. | [] |
NCT03343626 | 4.2.6 | Takeda Vaccine Candidate | 4.2.6 Takeda Vaccine Candidate Takeda's PIZV is an aluminum hydroxide (alum)-adjuvanted vaccine candidate made from purified formalin-inactivated ZIKV. The virus seed was derived from ZIKV strain PRVABC59 propagated through infection of Vero cells (derived from the kidney of African green monkey) grown in culture, and ... | [] |
NCT03343626 | 4.2.7 | Rationale for ZIK-101 Trial | 4.2.7 Rationale for ZIK-101 Trial The proposed ZIK-101 clinical trial is an observer-blind placebo-controlled first-in-human study. The rationale for the observer-blind approach is based on the different physical appearance of the investigational vaccine compared to the saline solution placebo that was selected and pre... | [] |
NCT03343626 | 5.0 | TRIAL OBJECTIVES AND ENDPOINTS | 5.0 TRIAL OBJECTIVES AND ENDPOINTS | [] |
NCT03343626 | 5.1 | Objectives | 5.1 Objectives | [] |
NCT03343626 | 5.1.1 | Primary Objectives | 5.1.1 Primary Objectives - To describe the safety of two doses of PIZV given 28 days apart from three different antigen concentrations (2, 5 or 10 µg) in flavivirus naïve and primed healthy adults through 28 days post dose 2 rimed - To select a single vaccine dose level of PIZV for further clinical development | [] |
NCT03343626 | 5.1.2 | Secondary Objectives | 5.1.2 Secondary Objectives - To describe the safety of two doses of PIZV given 28 days apart in flavivirus naïve and primed healthy adults through the end of the study - To describe the immune response to PIZV in flavivirus naïve and primed healthy adults at the following immunogenicity time points 28 days post dose 1,... | [] |
NCT03343626 | 5.2 | Endpoints | 5.2 Endpoints | [] |
NCT03343626 | 5.2.1 | Primary Endpoints | 5.2.1 Primary Endpoints Safety and Tolerability of PIZV, as determined by: - Percentage of subjects with solicited local reactions (injection site: pain, erythema, swelling, and induration), in each severity category, during the 7-day period after administration of each dose of PIZV or placebo. 7 placebo - Percentage o... | [] |
NCT03343626 | 5.2.2 | Secondary Endpoints | 5.2.2 Secondary Endpoints Safety of PIZV, as determined by: Percentage of subjects experiencing SAEs throughout the trial. Immunogenicity of PIZV, as determined by: - GMT of neutralizing anti-ZIKV antibody levels at 28 days post dose 1, and 6, 12, and 24 months post dose 2 in applicable groups. ZIKV eropositivity - Ser... | [] |
NCT03343626 | 6.0 | TRIAL DESIGN AND DESCRIPTION | 6.0 TRIAL DESIGN AND DESCRIPTION | [] |
NCT03343626 | 6.1 | Trial Design | 6.1 Trial Design This is a phase 1, randomized, observer-blind, placebo-controlled, safety, immunogenicity, and dose ranging study of PIZV candidate in flavivirus naïve and primed healthy adults aged ≥18 to ≤49 years, in ZIKV endemic and non-endemic regions. The trial will last approximately 7 or 25 months for each sub... | [] |
NCT03343626 | 6.2 | Justification for Trial Design, Dose, and Endpoints | 6.2 Justification for Trial Design, Dose, and Endpoints The trial design and the collection of solicited and unsolicited AEs following vaccination are consistent with guidelines on vaccine evaluation trials, including dose-finding studies. The design of the study answers to the principles outlined in the ICH Considerat... | [] |
NCT03343626 | 6.3 | Duration of Subject's Expected Participation in the Entire Trial 's | 6.3 Duration of Subject's Expected Participation in the Entire Trial 's Each enrolled subject's participation in the trial will last approximately 7 or 25 months, following a screening period prior to Visit 2 of two-weeks for flavivirus naïve subjects and of more than two weeks for flavivirus primed subjects. | [] |
NCT03343626 | 6.4 | Premature Termination or Suspension of Trial or Investigational Site | 6.4 Premature Termination or Suspension of Trial or Investigational Site | [] |
NCT03343626 | 6.4.1 | Criteria for Premature Termination or Suspension of the Trial | 6.4.1 Criteria for Premature Termination or Suspension of the Trial The trial will be completed as planned unless one or more of the following criteria are satisfied that require temporary suspension or early termination of the trial. - New information or other evaluation regarding the safety or efficacy of the investi... | [] |
NCT03343626 | 6.4.2 | Criteria for Premature Termination or Suspension of Investigational Sites | 6.4.2 Criteria for Premature Termination or Suspension of Investigational Sites A trial site may be terminated prematurely or suspended if the site (including the investigator) is found in significant deviation from GCP, protocol, or contractual agreement, is unable to ensure adequate performance of the trial, or as ot... | [] |
NCT03343626 | 6.4.3 | Procedures for Premature Termination or Suspension of the Trial or the Participation of Investigational Site(s) | 6.4.3 Procedures for Premature Termination or Suspension of the Trial or the Participation of Investigational Site(s) In the event that the sponsor, an institutional review board (IRB)/independent ethics committee (IEC) or regulatory authority elects to terminate or suspend the trial or the participation of an investig... | [] |
NCT03343626 | 7.0 | SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS | 7.0 SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS All entry criteria, including test results, need to be confirmed prior to randomization. | [] |
NCT03343626 | 7.1 | Inclusion Criteria | 7.1 Inclusion Criteria Subject eligibility is determined according to the following criteria: - 1. The subject is aged ≥18 to ≤49 years. - 2. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and eligibility screening te... | [] |
NCT03343626 | 7.2 | Exclusion Criteria | 7.2 Exclusion Criteria Any subject who meets any of the following criteria will not qualify for entry into the trial: - 1. Subjects and subjects' partners with confirmed ZIKV infection by self-report. self - 2. Traveling to flavivirus endemic countries or flavivirus endemic regions of the US/US territories\, within 4 w... | [
"Temporary screening failure"
] |
NCT03343626 | 7.3 | Criteria for Delay of Vaccination and/or Blood Sampling | 7.3 Criteria for Delay of Vaccination and/or Blood Sampling After enrollment, subjects may encounter clinical circumstances that warrant a delay in the administration of the subsequent dose of investigational vaccine/placebo. These situations are listed below: - Individuals with a clinically significant active infectio... | [] |
NCT03343626 | 7.4 | Criteria for Early Study Termination of a Subject rly | 7.4 Criteria for Early Study Termination of a Subject rly Under some circumstances, a subject's trial participation may be terminated early. This means that no further trial procedures (including data collection) will be performed on that subject beyond the specific date of early termination. The primary reason for ear... | [] |
NCT03343626 | 7.5 | Criteria for Premature Discontinuation of Trial Vaccine Application | 7.5 Criteria for Premature Discontinuation of Trial Vaccine Application Early (premature) study termination of a subject will by default prevent the subject from continued Trial Vaccine administration, as the subject will no longer be participating in the study. In addition to early termination (see Section 7.4) criter... | [] |
NCT03343626 | 8.0 | CLINICAL TRIAL MATERIAL MANAGEMENT | 8.0 CLINICAL TRIAL MATERIAL MANAGEMENT This section contains information regarding all vaccines and materials provided directly by the sponsor, and/or sourced by other means, that are required by the trial protocol, including important sections describing the management of clinical trial material. | [] |
NCT03343626 | 8.1 | Trial Vaccines and Materials | 8.1 Trial Vaccines and Materials | [] |
NCT03343626 | 8.1.1 | Dosage Form, Manufacturing, Packaging, and Labeling | 8.1.1 Dosage Form, Manufacturing, Packaging, and Labeling In this protocol, the investigational vaccine (PIZV) refers to Zika purified formalin-inactivated virus formulated with 200 µg aluminum hydroxide, Al(OH)3, as adjuvant, in phosphate buffered saline solution (PBS). The final liquid formulated product is filled in... | [] |
NCT03343626 | 8.1.2 | Storage | 8.1.2 Storage PIZV/placebo will be shipped in refrigerated and temperature-monitored containers. From receipt and prior to use, the investigational vaccine and the placebo must be protected from light and stored at 2°C to 8°C in a temperature monitored refrigerator with controlled access available only to authorized tr... | [] |
NCT03343626 | 8.1.3 | Dose and Regimen | 8.1.3 Dose and Regimen Three formulations of the vaccine containing different antigen concentrations will be used, where low dose contains 2 µg, medium dose contains 5 µg, and high dose contains 10 µg of the vaccine. Each dose will be packaged and appropriately labeled in compliance with regional regulatory requirement... | [] |
NCT03343626 | 8.2 | Investigational Vaccine/Placebo Assignment and Dispensing Procedures | 8.2 Investigational Vaccine/Placebo Assignment and Dispensing Procedures
PRECAUTIONS TO BE OBSERVED IN ADMINISTERING THE TRIAL VACCINE: Trial vaccines should not be administered to individuals with known hypersensitivity to any component of the vaccines. Standard immunization practices are to be observed and care shou... | [
"PRECAUTIONS TO BE OBSERVED IN ADMINISTERING THE TRIAL VACCINE:"
] |
NCT03343626 | 8.3 | Randomization Code Creation and Storage | 8.3 Randomization Code Creation and Storage Randomization personnel of the IRT provider or designee will generate the randomization schedule(s). Randomization information will be stored in a secured area, accessible only by authorized personnel. | [] |
NCT03343626 | 8.4 | Investigational Product Blind Maintenance | 8.4 Investigational Product Blind Maintenance This trial is an observer-blind study. The subjects, data collectors (eg, investigator), and data evaluators (eg, trial statisticians) are blinded to the material administered. The investigational product assignment will be maintained by the unblinded site staff designee. b... | [] |
NCT03343626 | 8.5 | Unblinding Procedure | 8.5 Unblinding Procedure The investigational vaccine/placebo blind shall not be broken by the investigator unless information concerning the investigational vaccine/placebo is necessary for the medical treatment of the subject. In the event of a medical emergency, if possible, the medical monitor should be contacted be... | [] |
NCT03343626 | 8.6 | Accountability and Destruction of Sponsor-Supplied Vaccine/Placebo | 8.6 Accountability and Destruction of Sponsor-Supplied Vaccine/Placebo Investigational vaccine/placebo supplies will be counted and reconciled at the site before being returned to the sponsor or designee as noted below. Sites will maintain source documents in addition to entering data in the IRT. The investigator or de... | [] |
NCT03343626 | 9.0 | TRIAL PLAN | 9.0 TRIAL PLAN | [] |
NCT03343626 | 9.1 | Trial Procedures | 9.1 Trial Procedures The following sections describe the trial procedures and data to be collected. For each procedure, subjects are to be assessed by the same investigator or site personnel whenever possible. The Schedule of Trial Procedures is located in Section 2.1. | [] |
NCT03343626 | 9.1.1 | Informed Consent | 9.1.1 Informed Consent The requirements of the informed consent are described in Section 15.2. Informed consent must be obtained at Screening Visit (1A or 1B), prior to the subject entering into the trial and before any protocol-directed procedures are performed. A unique subject ID number will be assigned at Screening... | [] |
NCT03343626 | 9.1.2 | Demographics, Medical History, Travel History, Prior/Concomitant Medications/Vaccinations, and Blood Donation History , | 9.1.2 Demographics, Medical History, Travel History, Prior/Concomitant Medications/Vaccinations, and Blood Donation History , Demographic information, to be obtained at Screening Visit (1A or 1B), will include age (date of birth), sex, race, and ethnicity as provided by the subject. Refer to Section 6.1 for more detail... | [
"Prohibited Therapies (See Section 7.2)"
] |
NCT03343626 | 9.1.3 | Documentation of Trial Entrance/Randomization ntrance/Randomization | 9.1.3 Documentation of Trial Entrance/Randomization ntrance/Randomization Only subjects who have signed an ICF at Screening Visit (1A or 1B), meet all of the inclusion criteria and none of the exclusion criteria, are eligible for entrance/randomization into the vaccination phase. One single subject ID number will be as... | [] |
NCT03343626 | 9.1.4 | Physical Examination | 9.1.4 Physical Examination Physical examinations must be performed by a qualified health professional in accordance with local regulations and licensing requirements designated within the Site Responsibility Delegation Log. Complete physical examination, including height and weight, will be performed at Screening Visit... | [] |
NCT03343626 | 9.1.5 | Vital Signs | 9.1.5 Vital Signs Vital signs include (however, not limited to) systolic/diastolic blood pressure, pulse rate, respiratory rate, and temperature. Follow standard of care for trial population and operational feasibility. Vital signs must be within normal limits (ie, below Grade 1 as specified in the FDA Toxicity Grading... | [] |
NCT03343626 | 9.1.6 | Blood Sample and Urine Sample Collection | 9.1.6 Blood Sample and Urine Sample Collection Blood samples will be collected at each site visit: ie, at Screening Visit(s) (Visit 1A and/or Visit 1B) for flavivirus serostatus determination (see Section 9.1.6.1) and eligibility screening tests (including pregnancy testing) (see Section 9.1.6.2), at Visits 3 and 5 for... | [] |
NCT03343626 | 9.1.6.1 | Flavivirus Serostatus Determination | 9.1.6.1 Flavivirus Serostatus Determination All subjects who sign the ICF will be tested for flavivirus serostatus determination at Screening Visit (1A or 1B). For Screening, the subject's serostatus relevant to major flavivirus(es) will be evaluated (including but not limited to Dengue, ZIKA, West Nile, Japanese Encep... | [] |
NCT03343626 | 9.1.6.2 | Eligibility Screening Tests | 9.1.6.2 Eligibility Screening Tests Screening laboratory tests that will be performed on blood and urine samples at Screening Visit(s) (Visit 1A and/or Visit 1B) are outlined in Table 9.a. Screen In order for the subjects to be enrolled, they must have laboratory values within normal limits or not be above Grade 1 as d... | [] |
NCT03343626 | 9.1.6.3 | Safety Laboratory Testing | 9.1.6.3 Safety Laboratory Testing | [] |
NCT03343626 | 9.1.6.4 | Immunogenicity Assessments | 9.1.6.4 Immunogenicity Assessments | [] |
NCT03343626 | 9.1.7 | Safety Assessments | 9.1.7 Safety Assessments During the trial, safety assessments will include collection and recording of solicited local (injection site) and systemic AEs (including fever), unsolicited AEs (serious and non-serious), and new medical conditions (neurological and neuroinflammatory disorders) with onset after the first vacc... | [] |
NCT03343626 | 9.1.8 | Contraception and Avoidance of Sexually Transmitted Disease Guidance | 9.1.8 Contraception and Avoidance of Sexually Transmitted Disease Guidance Subjects will be provided with information on acceptable methods of contraception and of protection against sexually transmitted diseases. Female subject of childbearing potential and sexually active will have to use an "acceptable contraceptive... | [] |
NCT03343626 | 9.1.9 | Pregnancy | 9.1.9 Pregnancy In women of childbearing potential, a serum pregnancy testing will be performed at Screening Visit(s) (Visit 1A and/or Visit 1B), and a urine pregnancy testing will be performed at Visit 2 (Day 1) before randomization (and thereby before investigational vaccine/placebo dose 1 administration) for confirm... | [] |
NCT03343626 | 9.1.10 | Documentation of Subjects who are not Randomized | 9.1.10 Documentation of Subjects who are not Randomized Investigators must account for all subjects who sign an ICF. If the subject is found to be not eligible at this visit, the investigator should complete the eCRF. The IRT supplier should be contacted as a notification of non-randomization. The primary reason for no... | [] |
NCT03343626 | 9.2 | Monitoring Subject Treatment Compliance | 9.2 Monitoring Subject Treatment Compliance The investigator records all injections of investigational vaccine/placebo given to the subject in the eCRF. | [] |
NCT03343626 | 9.3 | Schedule of Observations and Procedures | 9.3 Schedule of Observations and Procedures The schedule for all trial-related procedures for all evaluations is shown in Section 2.1. Assessments should be completed at the designated visit(s)/time point(s). | [] |
NCT03343626 | 9.3.1 | Screening Procedures (Screening Visit 1A/ Screening Visit 1B) | 9.3.1 Screening Procedures (Screening Visit 1A/ Screening Visit 1B) Refer to Section 6.1 for more details about the staggered enrollment. The following screening procedures will be performed at Screening Visit(s) (Visit 1A and/or Visit 1B): - 1. Confirm informed consent, and complete and collect ICF (see Section 9.1.1)... | [] |
NCT03343626 | 9.3.2 | Pre-Vaccination Procedures (Day 1 and Day 29) | 9.3.2 Pre-Vaccination Procedures (Day 1 and Day 29) The following procedures will be performed at Visit 2 (Day 1) and Visit 4 (Day 29): - 1. Collect medical history, travel history (to flavivirus endemic countries and flavivirus endemic regions of the US/US territories), and concomitant medications/vaccinations (see Se... | [] |
NCT03343626 | 9.3.3 | Vaccination Procedures (Day 1 and Day 29) | 9.3.3 Vaccination Procedures (Day 1 and Day 29) The following procedures will be performed at Visit 2 (Day 1) and Visit 4 (Day 29): - 1. Check contraindications to vaccination and criteria for delay of vaccination (see Sections 7.2 and 7.3). - 2. Prepare the investigational vaccine/placebo according to the Pharmacy Man... | [] |
NCT03343626 | 9.3.4 | Post Vaccination Procedures (Day 1 and Day 29) | 9.3.4 Post Vaccination Procedures (Day 1 and Day 29) The following post-vaccination procedures will be performed at Visit 2 (Day 1) and Visit 4 (Day 29): vaccination - 1. After vaccination, the subject will be observed for at least 30 minutes including observation for immediate reactions and body temperature measuremen... | [
"Please note:"
] |
NCT03343626 | 9.3.5 | Clinic Visits after Vaccination (Day 8, Day 36, Day 57, Day 211, and Day 393) | 9.3.5 Clinic Visits after Vaccination (Day 8, Day 36, Day 57, Day 211, and Day 393) The following procedures will be performed at Visit 3 (Day 8), Visit 5 (Day 36), Visit 6 (Day 57), and for subjects randomized to the placebo group or the PIZV dosing group that was selected for further development, Visit 8 (Day 211) an... | [] |
NCT03343626 | 9.3.6 | Phone Contacts (Day 133 and Day 575) | 9.3.6 Phone Contacts (Day 133 and Day 575) A phone contact will be made on Day 133 (Visit 7) and Day 575 (Visit 10) with each subject to collect SAEs that may have occurred since Visit 6 (Day 57) and Visit 9 (Day 393), respectively, and to remind the subject of the next planned (end of) trial activity. The subject will... | [] |
NCT03343626 | 9.3.7 | Final Visit (Day 211 or Day 757) | 9.3.7 Final Visit (Day 211 or Day 757) The Final Visit will be performed at Visit 8 (Day 211) or, for subjects randomized to the placebo group or the PIZV dosing group that was selected for further development, Visit 11 at Day 757 (24 months post dose 2). If a subject terminates earlier, Final Visit procedures should b... | [] |
NCT03343626 | 9.3.8 | Post-Trial Care | 9.3.8 Post-Trial Care No post-trial care will be provided. | [] |
NCT03343626 | 9.4 | Biological Sample Retention and Destruction | 9.4 Biological Sample Retention and Destruction In this trial, specimens for immune response testing will be collected as described in Section 9.1.6.4. After blood draw and serum processing, the serum samples will be preserved and retained at a central storage location that was contracted by the sponsor for this purpos... | [] |
NCT03343626 | 10.0 | ADVERSE EVENTS | 10.0 ADVERSE EVENTS | [] |
NCT03343626 | 10.1 | Definitions | 10.1 Definitions | [] |
NCT03343626 | 10.1.1 | Adverse Events (AEs) | 10.1.1 Adverse Events (AEs) | 10.0 | ADVERSE EVENTS | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03343626 | 10.1.2 | Solicited Adverse Events | 10.1.2 Solicited Adverse Events Table 10.a Local and Systemic AEs | Local AEs (injection site): | Pain | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | | ofErythema | | | msSwelling | | | TerInd... | [] |
NCT03343626 | 10.1.3 | Serious Adverse Events (SAEs) | 10.1.3 Serious Adverse Events (SAEs) An SAE is defined as any untoward medical occurrence that: - 1. Results in DEATH. - 2. Is LIFE THREATENING. - The term "life threatening" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event that hypothetically might ha... | [] |
NCT03343626 | 10.2 | Causality of AEs | 10.2 Causality of AEs Relatedness (causality) to vaccine will also be assessed by the investigator. The relationship of each AE, including solicited systemic AEs (solicited local AEs are considered as related) to trial vaccine(s) will be assessed using the following categories: Property of Takeda: For Non-Commercial Us... | [] |
NCT03343626 | 10.2.1 | Relationship to Trial Procedures | 10.2.1 Relationship to Trial Procedures Relationship (causality) to trial procedures should be determined for all AEs. The relationship should be assessed as "Yes" if the investigator considers that there is reasonable possibility that an event is due to a trial procedure. Otherwise, the relationship should be assessed... | [] |
NCT03343626 | 10.2.2 | Outcome of AEs | 10.2.2 Outcome of AEs Resolved: The subject has fully recovered from the event or the condition has returned to the level observed at baseline Resolving: The event is improving but the subject is still not fully recovered Not resolved: The event is ongoing at the time of reporting and the subject has still not recovere... | [] |
NCT03343626 | 10.3 | Additional Points to Consider for AEs | 10.3 Additional Points to Consider for AEs An untoward occurrence generally may: - Indicate a new diagnosis or unexpected worsening of a pre-existing condition. Intermittent events for pre-existing conditions or underlying disease should not be considered as AEs. umstances pre - Necessitate therapeutic intervention. - ... | [
"Diagnoses vs signs and symptoms:",
"Worsening of AEs:",
"Changes in severity of AEs:",
"Preplanned surgeries or procedures:",
"Elective surgeries or procedures:"
] |
NCT03343626 | 10.4 | Procedures | 10.4 Procedures | [] |
NCT03343626 | 10.4.1 | Collection and Reporting of AEs | 10.4.1 Collection and Reporting of AEs All AEs, whether considered related with the use of the investigational vaccine/placebo or not, must be monitored until symptoms subside and any abnormal laboratory values have returned to baseline, or until there is a satisfactory explanation for the changes observed, or until de... | [] |
NCT03343626 | 10.4.2 | Collection and Reporting of Solicited AEs | 10.4.2 Collection and Reporting of Solicited AEs The occurrence of selected indicators of safety will be collected on diary cards by the subjects for 7 days following each investigational vaccine/placebo administration (ie, the day of vaccination +6 subsequent days) and will be recorded on the "Local and Systemic AE" e... | [] |
NCT03343626 | 10.4.3 | Collection and Reporting of SAEs | 10.4.3 Collection and Reporting of SAEs Collection of SAEs will commence from the time that the subject is first administered the investigational vaccine/placebo (Day 1). Routine collection of SAEs will continue up to the end of the trial at Visit 8 (Day 211) or Visit 11 (Day 757) for subjects who were randomized to th... | [
"Causality assessment."
] |
NCT03343626 | 10.5 | Follow-up Procedures | 10.5 Follow-up Procedures | [] |
NCT03343626 | 10.5.1 | AEs | 10.5.1 AEs All AEs will be monitored until resolution or a stable status is reached or until a formal diagnosis can be made or until the end of the trial, whichever occurs first. | [] |
NCT03343626 | 10.5.2 | SAEs | 10.5.2 SAEs If information not available at the time of the first report becomes available at a later date, the investigator should complete a follow-up SAE form or provide other written documentation and fax it immediately within 24 hours of receipt. Copies of any relevant data from the hospital notes (eg, laboratory ... | [] |
NCT03343626 | 10.5.3 | Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities | 10.5.3 Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities The sponsor or designee will be responsible for the reporting of all suspected unexpected serious adverse reactions (SUSARs) and any other applicable SAEs to regulatory authorities, investigators and IRBs or IECs, as applicable, in accor... | [] |
NCT03343626 | 10.5.4 | Post-Trial Events | 10.5.4 Post-Trial Events Any SAE that occurs outside of the protocol-specified observation period or after the end of the trial but considered to be caused by the trial vaccine(s) must be reported to the sponsor. These SAEs will be processed by the sponsor's Pharmacovigilance Department. Instructions for how to submit ... | [] |
NCT03343626 | 11.0 | TRIAL-SPECIFIC REQUIREMENTS | 11.0 TRIAL-SPECIFIC REQUIREMENTS | [] |
NCT03343626 | 11.1 | Data Monitoring Committee Guidelines for Possible Study Pause | 11.1 Data Monitoring Committee Guidelines for Possible Study Pause The external DMC will review safety data on an ongoing basis (refer to Section 11.2.1). More specifically, when the following set of AEs are reported, the external DMC will review all relevant safety data within 48 hours and consider a possible pause of... | [] |
NCT03343626 | 11.2 | Trial-Specific Committees | 11.2 Trial-Specific Committees | [] |
NCT03343626 | 11.2.1 | External Data Monitoring Committee | 11.2.1 External Data Monitoring Committee An external DMC will have oversight of this trial. The external DMC functions at a program level and further information is available in the external DMC Charter. The external DMC may review the data in an unblinded manner; however, the study team will remain blinded. The exter... | [] |
NCT03343626 | 12.0 | DATA HANDLING AND RECORDKEEPING | 12.0 DATA HANDLING AND RECORDKEEPING The full details of procedures for data handling will be documented in the Data Management Plan. AEs, medical history, and concurrent conditions will be coded using the Medical Dictionary for Regulatory Activities (MedDRA – System Organ Class [SOC], High Level Group Term [HLGT], Hig... | [] |
NCT03343626 | 12.1 | Electronic CRFs (eCRF) | 12.1 Electronic CRFs (eCRF) Completed eCRFs are required for each subject who provides a signed ICF. The sponsor or its designee will supply investigative sites with access to eCRFs. The sponsor will make arrangements to train appropriate site staff in the use of the eCRF. These forms are used to transmit the informati... | [] |
NCT03343626 | 12.2 | Record Retention | 12.2 Record Retention The investigator agrees to keep the records of the eCRF and those documents that include (but are not limited to) the trial-specific documents, the identification log of all participating subjects, source documents. Temporary media such as thermal sensitive paper should be copied and certified, so... | [] |
NCT03343626 | 13.0 | STATISTICAL METHODS | 13.0 STATISTICAL METHODS | [] |
NCT03343626 | 13.1 | Statistical and Analytical Plans | 13.1 Statistical and Analytical Plans A statistical analysis plan (SAP) will be prepared and finalized prior to unblinding of subject's treatment assignment. This document will provide further details regarding the definition of analysis variables and analysis methodology to address all trial objectives. istical A blin... | [] |
NCT03343626 | 13.1.1 | Analysis Sets | 13.1.1 Analysis Sets - Safety Set: The Safety Set will consist of all randomized subjects who received at least one dose of the investigational vaccine/placebo. - Full Analysis Set (FAS): The FAS will include all randomized subjects who have received at least one dose of the investigational vaccine/placebo and provided... | [] |
NCT03343626 | 13.1.2 | Analysis of Demographics and Other Baseline Characteristics | 13.1.2 Analysis of Demographics and Other Baseline Characteristics Summaries of age, gender, race, and other baseline characteristics will be presented by formulation arm. g | [] |
NCT03343626 | 13.1.3 | Immunogenicity Analysis | 13.1.3 Immunogenicity Analysis Seropositive subjects: Subjects with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. - Seronegative subjects: Subjects with no detectable serum antibodies (test results are below LOD) as measured by the neutralizat... | [] |
NCT03343626 | 13.1.4 | Safety Analysis | 13.1.4 Safety Analysis Reactogenicity will be assessed for 7 days following each dose (including day of vaccine/placebo administration) via daily collection of solicited AEs, including local reactions (injection site: pain, erythema, swelling, and induration) and systemic AEs of headache, fatigue, malaise, arthralgia a... | [] |
NCT03343626 | 13.2 | Interim Analysis and Sequence of Analyses | 13.2 Interim Analysis and Sequence of Analyses A first interim analysis will be performed to include immunogenicity and safety data from all flavivirus naïve subjects up to Visit 6 (on Day 57, 28 days post dose 2); a second interim analysis will be performed for dose selection, including safety data from all flavivirus... | [] |
NCT03343626 | 13.3 | Determination of Sample Size | 13.3 Determination of Sample Size The sample size was not determined based on formal statistical power calculations. Stochastic simulations suggest that the proposed sample size is deemed adequate under a variety of decision-making scenarios. making | [] |
NCT03343626 | 14.0 | QUALITY CONTROL AND QUALITY ASSURANCE | 14.0 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03343626 | 14.1 | Trial-Site Monitoring Visits | 14.1 Trial-Site Monitoring Visits Monitoring visits to the trial site will be made periodically during the trial to ensure that all aspects of the protocol are followed. Source documents will be reviewed for verification of data recorded on the eCRFs. Source documents are defined as original documents, data, and record... | [] |
NCT03343626 | 14.2 | Protocol Deviations | 14.2 Protocol Deviations The investigator should not deviate from the protocol, except where necessary to eliminate an immediate hazard to trial subjects. Should other unexpected circumstances arise that will require deviation from protocol-specified procedures, the investigator should consult with the medical monitor ... | [] |
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