protocol_id stringclasses 263
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NCT03104699 | 7.2.2.2 | Adverse Events of Special Interest | 7.2.2.2. Adverse Events of Special Interest In the event of a non-serious AESI, the investigator must complete the AESI report form and send it to the Sponsor/designee immediately, within 24 hours. Names, addresses, and telephone and fax numbers for AESI reporting will be included on the report form. Serious AESIs must... | [] |
NCT03104699 | 7.2.2.3 | Safety Reporting to HealthAuthorities, Independent Ethics Committees/ Institutional Review Boards, and Investigators | 7.2.2.3. Safety Reporting to HealthAuthorities, Independent Ethics Committees/ Institutional Review Boards, and Investigators The Sponsor will send appropriate safety notifications to health authorities in accordance with applicable laws and regulations. The investigator must comply with any applicable site-specific re... | [] |
NCT03104699 | 7.3 | Monitoring of Subjects with Adverse Events | 7.3. Monitoring of Subjects with Adverse Events Adverse events are recorded and assessed continuously throughout the trial starting at the time the subject receives his/her first treatment ([Section](#page-91-1) 7.2.1) and are assessed for final outcome at the end-of-treatment visit. After the End-of-Treatment Safety F... | [] |
NCT03104699 | 7.4 | Pregnancy and In Utero Drug Exposure | 7.4. Pregnancy and In Utero Drug Exposure Only pregnancies considered by the investigator as related to trial treatment (e.g., resulting from a drug interaction with a contraceptive medication) are considered as AEs. However, all pregnancies with an estimated conception date during the period defined in [Section](#page... | [] |
NCT03104699 | 7.5 | AGEN2034 Overdose | 7.5. AGEN2034 Overdose An overdose is defined as any dose 5% greater than the highest daily dose included in the clinical trial protocol. Any overdose must be recorded in the trial medication section of the eCRF. For monitoring purposes, any case of overdose, whether or not associated with an AE (serious or non-serious... | [] |
NCT03104699 | 8 | STATISTICAL CONSIDERATIONS | 8. STATISTICAL CONSIDERATIONS This section outlines the core elements of the planned statistical summaries and analyses for the data collected in this study. Detailed methodology for summary and statistical analyses of the data collected in this study will be documented in a Statistical Analysis Plan (SAP), which will ... | [] |
NCT03104699 | 8.1 | Sample Size | 8.1. Sample Size The study includes 2 phases: Phase 1: Dose Escalation Phase, and Phase 2: Expansion Phase. The total sample size for both phases is expected to be approximately 200 subjects. | [] |
NCT03104699 | 8.1.1 | Phase 1 | 8.1.1. Phase 1 It is expected that approximately 50 subjects will be enrolled in the Phase 1 part of the study. The sample size in the Phase 1 is not driven by statistical hypothesis testing, but driven by clinical considerations. Final sample size in this phase may vary depending on the total number of dose levels to ... | [] |
NCT03104699 | 8.1.2 | Phase 2 | 8.1.2. Phase 2 The aim in this phase is to detect preliminary evidence of clinical activity in subjects with metastatic cervical cancer. The primary endpoint is the ORR per IERC based on RECIST 1.1. ORR will be estimated as binomial proportion of best overall response (BOR) of confirmed PR Confidential Page 95 of 113 o... | [] |
NCT03104699 | 8.2 | Analysis Sets | 8.2. Analysis Sets The following analysis sets will be defined and used separately for Phase 1 and Phase 2, as applicable: - Phase 1 DLT analysis set: All subjects with data used for implementing the confirmation of the safety of the combination. These subjects should have received all study treatment administrations i... | [] |
NCT03104699 | 8.3 | Description of Statistical Analyses | 8.3. Description of Statistical Analyses | [] |
NCT03104699 | 8.3.1 | General Considerations | 8.3.1. General Considerations All data recorded during the study will be presented in individual data listings performed on the safety analysis set. All data will be evaluated as observed, and no imputation method for missing values will be used unless otherwise specified. All data will be presented in a descriptive ma... | [] |
NCT03104699 | 8.3.2 | Analysis of Primary Endpoints | 8.3.2. Analysis of Primary Endpoints | [] |
NCT03104699 | 8.3.2.1 | In Phase 1: Dose-limiting Toxicity | 8.3.2.1. In Phase 1: Dose-limiting Toxicity For determination of safety of AGEN2034, individual subject data from the Phase 1 portion of the trial will be reported. In addition, for final statistical analysis, the following will be summarized: - At each dose level, number and proportion of subjects in the DLT analysis ... | [] |
NCT03104699 | 8.3.2.2 | In Phase 2: Objective Response Rate | 8.3.2.2. In Phase 2: Objective Response Rate • The primary endpoint for Phase 2 is the confirmed ORR according to RECIST 1.1, as determined by an IERC. ORR will be estimated as the binomial proportion of patients with BOR of PR or CR, taking into account the following requirement for confirmation: for PR or CR, confirm... | [] |
NCT03104699 | 8.3.3 | Analysis of Secondary Endpoints | 8.3.3. Analysis of Secondary Endpoints The following secondary endpoints will be summarized. | [] |
NCT03104699 | 8.3.3.1 | Efficacy Parameters | 8.3.3.1. Efficacy Parameters Efficacy parameters, including confirmed ORR according to RECIST 1.1, as determined by investigator; disease control rate (DCR), defined as proportion of subjects with CR, PR, or SD for at least 12 weeks; duration of response (DOR) according to RECIST 1.1; time to response (TTR); and durati... | [] |
NCT03104699 | 8.3.3.2 | Pharmacokinetic Parameters | 8.3.3.2. Pharmacokinetic Parameters Both noncompartmental (NCA) and compartmental modeling (e.g., population PK [PopPK]) techniques will be used to analyze AGEN2034 PK. The PK parameters to be estimated and reported may include, but may not be limited to: maximum drug concentration observed postdose at steady-state (Cm... | [] |
NCT03104699 | 8.3.3.3 | Immunogenicity | 8.3.3.3. Immunogenicity Antidrug antibody concentrations in correlation with AGEN2034 PK exposure matrix will be summarized. | [] |
NCT03104699 | 8.3.3.4 | Exploratory Biomarkers | 8.3.3.4. Exploratory Biomarkers Summary statistics for biomarkers will be provided for all preplanned time points. Changes from baseline for continuous biomarkers may also be presented as applicable and categorical biomarkers will be tabulated. Possible relationship of biomarker levels with efficacy may be investigated... | [] |
NCT03104699 | 8.3.4 | Safety Analyses | 8.3.4. Safety Analyses The extent of exposure to AGEN2034 will be characterized by duration (weeks), number of administrations, cumulative dose (mg/kg), dose intensity (mg/kg/week), relative dose intensity (actual dose given/planned dose), number of dose reductions, and number of dose delays. Safety analyses will be pe... | [] |
NCT03104699 | 8.3.4.1 | Adverse Events | 8.3.4.1. Adverse Events Adverse events will be coded according to Medical Dictionary for Regulatory Activities (MedDRA) version 21.0. Severity of AEs will be graded using CTCAE (version 4.03) toxicity grading scale whenever possible. Treatment-emergent AEs are AEs with onset dates during the on-treatment period, or the... | [] |
NCT03104699 | 8.3.4.2 | Laboratory Variables | 8.3.4.2. Laboratory Variables Laboratory results will be classified by grade according to NCI CTCAE. The worst on-trial grades after first trial treatment will be summarized. Shifts in toxicity grading from first treatment to highest grade will be tabulated. Results for variables that are not part of NCI CTCAE will be ... | [] |
NCT03104699 | 8.3.4.3 | Physical Examination, Vital Signs, and Electrocardiogram | 8.3.4.3. Physical Examination, Vital Signs, and Electrocardiogram Physical examination data, vital signs (body temperature, respiratory rate, heart rate, and blood pressure), and 12-lead ECG data will be presented. | [] |
NCT03104699 | 8.3.5 | Interim and Final Analysis | 8.3.5. Interim and Final Analysis Phase 2 is designed to have at least 2 interim analyses of the primary endpoint and selected secondary efficacy and safety endpoints. No early stopping for efficacy will be performed, as a more complete assessment of safety and durability of responses will be required for evaluation of... | [] |
NCT03104699 | 9 | TRIAL GOVERNANCE AND OVERSIGHT | 9. TRIAL GOVERNANCE AND OVERSIGHT | [] |
NCT03104699 | 9.1 | Safety Monitoring Committee | 9.1. Safety Monitoring Committee A Safety Monitoring Committee (SMC) will regularly review safety data to ensure subjects' safety throughout the study. The SMC will consist of permanent members from the Sponsor and/or CRO: - Sponsor: head of development/chief medical officer, pharmacovigilance physician, study physicia... | [] |
NCT03104699 | 9.2 | Independent Endpoint Review Committee | 9.2. Independent Endpoint Review Committee For the Phase 2 portion of the study, a central facility will read and interpret all radiographic scans for subjects enrolled in the study. Data for all images will be transferred from trial sites to the central reading center for evaluation. Scans will be evaluated at the cen... | [] |
NCT03104699 | 9.3 | Independent Data Monitoring Committee (IDMC) | 9.3. Independent Data Monitoring Committee (IDMC) For the Phase 2 portion of the study, an IDMC will be established supplement the routine trial monitoring outlined in this protocol. The voting members of the committee are external to and independent of the Sponsor. The members of the IDMC must not be involved with the... | [] |
NCT03104699 | 10 | ETHICAL AND REGULATORY ASPECTS | 10. ETHICAL AND REGULATORY ASPECTS | [] |
NCT03104699 | 10.1 | Ethics Review | 10.1. Ethics Review The study protocol, subject information and consent form, Investigator's Brochures and bridging Investigator's Brochure, any written instructions to be given to the subject, available safety information, subject recruitment procedures (e.g., study website), information about payments and compensatio... | [] |
NCT03104699 | 10.2 | Responsibilities of the Investigator | 10.2. Responsibilities of the Investigator The investigator is responsible for conduct of the trial at his/her site. He/she will ensure that the trial is performed in accordance with the clinical trial protocol and the approved protocol amendments; the current version of the Declaration of Helsinki (Ethical Principles ... | [] |
NCT03104699 | 10.3 | Subject Information and Informed Consent | 10.3. Subject Information and Informed Consent An unconditional prerequisite for a subject's participation in the trial is his/her written informed consent. The subject's written informed consent to participate in the trial must be given before any trial-related activities are carried out. Subjects may also sign a sepa... | [] |
NCT03104699 | 10.4 | Subject Identification and Privacy | 10.4. Subject Identification and Privacy In compliance with ICH GCP guidelines, it is a requirement that the investigator and institution permit authorized representatives of the Sponsor, regulatory authorities, and IRB direct access to review the subject's original medical records at the site for verification of trial... | [] |
NCT03104699 | 10.5 | Emergency Medical Support and Subject Card | 10.5. Emergency Medical Support and Subject Card Subjects enrolled in this clinical trial will be provided with emergency medical support cards during their trial participation, which will be furnished by the Sponsor or designee. The emergency medical support card is based on the need to provide clinical trial subjects... | [] |
NCT03104699 | 10.6 | Clinical Trial Insurance and Compensation to Subjects | 10.6. Clinical Trial Insurance and Compensation to Subjects Insurance coverage shall be provided for each country participating to the trial. Insurance conditions shall meet good local standards, as applicable. | [] |
NCT03104699 | 10.7 | Health Authorities | 10.7. Health Authorities The clinical trial protocol and any applicable documentation (e.g., investigational medicinal product dossier, subject information, and ICF) will be submitted or notified to health authorities by the Sponsor or designated CRO in accordance with regulations of the countries involved in the trial... | [] |
NCT03104699 | 11 | TRIAL MANAGEMENT | 11. TRIAL MANAGEMENT | [] |
NCT03104699 | 11.1 | Sponsor and Trial Administrative Structure | 11.1. Sponsor and Trial Administrative Structure The Sponsor of this study is Agenus Inc. In countries where a local sponsor is required a qualified local legal Sponsor will be designated by Agenus, and will act as the legal Sponsor for the study, and will fulfil the obligations that this role entails. In these cases, ... | [] |
NCT03104699 | 11.2 | Investigational Sites | 11.2. Investigational Sites The trial will be global, with approximately 10 to 15 enrolling centers participating in Phase 1 and approximately 60 centers in Phase 2. | [] |
NCT03104699 | 11.3 | Trial Coordination/Monitoring | 11.3. Trial Coordination/Monitoring The Sponsor will coordinate the trial and may delegate certain trial activities to CROs, including certain laboratory assessments, safety reporting, biostatistics, etc. The Sponsor's clinical operations department will oversee activities performed by CROs. Confidential Page 104 of 11... | [] |
NCT03104699 | 11.4 | Data Collection | 11.4. Data Collection The eCRF is the primary data collection instrument for the trial. The clinical site will keep eCRFs current to enable the monitor to review the subjects' status throughout the course of the trial. To maintain confidentiality, only the study number, subject number, subject initials, and date of bir... | [] |
NCT03104699 | 11.5 | Investigator Site File and Archiving | 11.5. Investigator Site File and Archiving The investigator will be provided with an investigator site file upon initiation of the trial. This file will contain all documents necessary for the conduct of the trial and will be updated by the site throughout the trial. It must be available for review by the monitor; be r... | [] |
NCT03104699 | 11.6 | Monitoring, Quality Assurance and Inspection by Health Authorities | 11.6. Monitoring, Quality Assurance and Inspection by Health Authorities This trial will be monitored in accordance with the current version of the ICH Good Clinical Practice guideline (ICH E6). The site monitor will visit the trial site at regular intervals. Representatives of the Sponsor's quality assurance unit or a... | [] |
NCT03104699 | 11.7 | Publication Policy | 11.7. Publication Policy | [] |
NCT03104699 | 11.7.1 | Clinical Trial Report | 11.7.1. Clinical Trial Report After completion of the trial, a clinical trial report according to ICH E3 guideline will be written by the Sponsor or designated CRO in consultation with the Principal Investigator. | [] |
NCT03104699 | 11.7.2 | Publications | 11.7.2. Publications All information provided regarding the trial, as well as all information collected/documented during the course of the trial, will be regarded as confidential. The Sponsor reserves the right to release literature publications based on the results of the trial. Results from the trial will be publish... | [] |
NCT03104699 | 12 | REFERENCES | 12. REFERENCES Allie SR, Zhang W, Fuse S, Usherwood EJ. 2011. Programmed death 1 regulates development of central memory CD8 T cells after acute viral infection. J Immunol 186(11):6280–6286. Amin MB, Edge S, Greene F, et al, eds. 2017. AJCC Cancer Staging Manual. 8th ed. Springer International Publishing: American Join... | [
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NCT03116113 | A | DOSE ESCALATION (PHASE 1), AND DOSE EXPANSION (PHASE 2/3) CLINICAL TRIAL OF RETINAL GENE THERAPY FOR X-LINKED RETINITIS PIGMENTOSA USING AN ADENO-ASSOCIATED VIRAL VECTOR (AAV8) ENCODING RETINITIS PIGMENTOSA GTPASE REGULATOR (RPGR) | A DOSE ESCALATION (PHASE 1), AND DOSE EXPANSION (PHASE 2/3) CLINICAL TRIAL OF RETINAL GENE THERAPY FOR X-LINKED RETINITIS PIGMENTOSA USING AN ADENO-ASSOCIATED VIRAL VECTOR (AAV8) ENCODING RETINITIS PIGMENTOSA GTPASE REGULATOR (RPGR)
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NCT03205046 | A | DLT excludes: | A DLT excludes: - 1. Alopecia of any grade - 2. Isolated laboratory changes of any grade without clinical sequelae or clinical significance
Study Objectives: Primary Objectives:
Part 1 Objective: To determine a dose and schedule for vistusertib in combination with acalabrutinib 100 mg bid for evaluation in Part 2
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NCT03220737 | P | R O T O C O L SI G N A T U R E S H E E T | P R O T O C O L SI G N A T U R E S H E E T A P h ase 4 St u d y t o Assess t he S afet y a n d I m m u n o ge n icit y of V A X C H O R A (C h oler a V a cci ne, Li ve, Or al) i n C hil dre n 2 t o < 1 8 Ye ars of A ge T he i nf or mati o n c o ntai ne d i n t his d oc u me nt a n d all i nf or mati o n pr o vi de d t ... | [] |
NCT03220737 | P | R O T O C O L S Y N O P SI S | P R O T O C O L S Y N O P SI S | P R O T O C O L TI T L E | A P hase4 St u d y t oAssess t he Safet y a n d I m m u n o ge nicit y ofV A X C H O R A(C h olera Vacci n e, Li ve, Oral ) i n C hil dre n 2 t o Years of A ge | |-----------------------------------------------|-------------------------------------------------... | [] |
NCT03220737 | S | T U D Y P R O C E D U R E S | S T U D Y P R O C E D U R E S | [] |
NCT03220737 | S | afet y : | S afet y : S u bjects will be m o nit ore d f or ac ute reacti o ns f or 3 0 mi n utes after vacci nati o n. A d v erse e ve nts of a b d o mi nal pai n, h ea dac he, la c k of a p petite, tire d ness, diarr hea, na usea, v o miti n g a n d fe ver will be s olicite d dail y t hr o u g h D a y 8 (a n d fr o m Da y 1 8 1... | [
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NCT03220737 | S | T A TI S TI C A L M E T H O D S | S T A TI S TI C A L M E T H O D S S olicite d A E s will be s u m marize d b y t he p erce nt of s u bjects b y treat me nt gr o u p w h o e x perie nce eac h s olicite d a d verse e ve nt at least o nce. A sec o n d ta ble will prese nt a si milar s u m mar y c o nstrai ne d t o s olicite d A Es of m o derate se verit... | [
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NCT03220737 | S | a m ple Size R ati o n ale | S a m ple Size R ati o n ale Ass u mi n g t hat t he tr ue ser oc o n versi o n rate a m o n g 1 2 t o < 1 8 -year ol ds is 9 2. 4 % or hi g her, t he sa m ple size of 1 4 3 e val ua ble vacci nees f or t hat a g e c o h ort aff or ds 93 . 3 % p o wer t o de m o nstrate t hat t he ser oc o n versi o n rat e wit hi n t ... | [
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NCT03220737 | S | a fet y | S a fet y T he safet y of V A X C H O R A was e val uate d i n f o ur ra n d o mize d, place b o -c o ntr olle d, m ultice nter cli nical trials. A t otal of 3 2 3 5 a d ults 1 8 t hr o u g h 6 4 years of a ge recei ve d o ne d ose of V A X C H O R A a n d 5 6 2 recei v e d place b o [ p h ysi ol o gic sali ne ( N = 5 ... | [
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NCT03220737 | T | a ble f or Cli nic al A b n or m alities | T a ble f or Cli nic al A b n or m alities | V A C CI N ER E A C TI O N | MI L D ( Gr a de 1) | M O D E R A T E ( Gr a de 2) | S E V E R E ( Gr a de 3) | P O T E N TI A L L Y LI F ET H R E A T E NI N G ( Gr a de4) | | |---------------------------------------------|----------------------------------------------------|--... | [
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NCT03232567 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY | [] |
NCT03232567 | 1.1 | Synopsis | 1.1 Synopsis | Sponsor:Altimmune, Inc. | | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------... | [
"Statistical Methods:",
"Analyses:",
"Safety",
"Immunogenicity"
] |
NCT03232567 | 1.2 | Schedule of Events | 1.2 Schedule of Events | | | Dosing Period | | | | | | | Follow-up Period | | |-------------------------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------... | [] |
NCT03232567 | 2 | INTRODUCTION | 2 INTRODUCTION | [] |
NCT03232567 | 2.1 | Seasonal Influenza | 2.1 Seasonal Influenza Influenza is one of the most common viral respiratory infections, leading to significant morbidity and mortality. In particular, individuals with chronic medical conditions or who are pregnant or at the extremes of age are vulnerable to developing influenza-related complications [\[CDC 2016\]](#p... | [] |
NCT03232567 | 2.2 | Current Vaccines for Seasonal Influenza | 2.2 Current Vaccines for Seasonal Influenza The CDC recommends that everyone in the United States over 6 months of age receive an annual influenza vaccination. Most currently licensed vaccines are based on circulating influenza strains adapted to grow in chicken eggs. The viruses are harvested, inactivated, and combine... | [] |
NCT03232567 | 2.3 | NasoVAX | 2.3 NasoVAX Adenovirus is a naturally occurring respiratory virus that has been used frequently as a vector to introduce genetic material into cells. By incorporating the influenza HA gene into replicationdeficient (RD) adenovirus (Ad-HA) and applying the Ad-HA into the nose, the adenoviral vector can transduce the HA ... | [] |
NCT03232567 | 2.4 | Nonclinical Studies | 2.4 Nonclinical Studies The Sponsor has conducted nonclinical studies of immunogenicity, lethal challenge, biodistribution, and single-dose and repeat-dose toxicity with Ad5-vectored vaccines incorporating other influenza genetic inserts and with a similar Ad5-vectored vaccine AdVAV (Ad5-vectored anthrax vaccine). Addi... | [] |
NCT03232567 | 2.5 | Previous Clinical Experience with Adenoviral Vectors | 2.5 Previous Clinical Experience with Adenoviral Vectors The ability of RD-Ad5 vectors to adequately express the protein of interest following parenteral administration in the presence of pre-existing immunity to wild-type (WT) Ad5 has been a concern [\[Yang1994\]](#page-53-4). However, several lines of evidence, inclu... | [] |
NCT03232567 | 2.6 | Clinical Trials of NasoVAX | 2.6 Clinical Trials of NasoVAX The immunogenicity and safety of Ad-5 vectored influenza vaccines has been evaluated in 2 Phase 1 studies in healthy volunteers. These studies involved doses similar to the lowest dose being delivered in the this study or lower. The vaccines were well tolerated. Immune responses were weak... | [] |
NCT03232567 | 2.7 | Study Rationale | 2.7 Study Rationale This study is designed to evaluate safety and immunogenicity of a monovalent A/California/04/2009(H1N1)-like strain version of NasoVAX, testing doses similar to and higher than those tested in previous Phase 1 studies. Exploratory endpoints will evaluate the breadth of antibody response and the abil... | [] |
NCT03232567 | 2.8 | Benefit/Risk Assessment | 2.8 Benefit/Risk Assessment On the basis of nonclinical and clinical study results to date, the efficacy issues associated with existing influenza vaccines, and the potential morbidity and mortality associated with influenza, NasoVAX is considered to have a positive benefit-risk profile for healthy adults aged 18 to 49... | [] |
NCT03232567 | 3 | STUDY OBJECTIVES AND ENDPOINTS | 3 STUDY OBJECTIVES AND ENDPOINTS | ENDPOINTS | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03232567 | 4 | STUDY DESIGN | 4 STUDY DESIGN | [] |
NCT03232567 | 4.1 | Overall Study Design | 4.1 Overall Study Design The Schedule of Events showing time points for all study procedures is provided in Section [1.2.](#page-13-0) This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be sc... | [] |
NCT03232567 | 4.2 | Study Design Rationale | 4.2 Study Design Rationale | [] |
NCT03232567 | 4.2.1 | Population | 4.2.1 Population Healthy, immunocompetent adults aged 18 to 49 years were selected as the population for this study to minimize risk to subjects and to maximize the potential to produce an immune response. | [] |
NCT03232567 | 4.2.2 | Dose | 4.2.2 Dose The initial dose to be tested in this study (1×109 vp) is in the range of intranasal doses that were shown to be safe and modestly immunogenic in earlier clinical trials of NasoVAX (Section [2.6](#page-17-2)). Escalation is planned to the NOAEL (1×1011 vp) established in the GLP repeat-dose toxicology study ... | [] |
NCT03232567 | 4.2.3 | Assessments | 4.2.3 Assessments
Safety An evaluation of safety is the primary objective for this study of NasoVAX that will evaluate doses higher than tested in the previous Phase 1 studies of this adenoviral vector. Safety assessments are standard for early-phase clinical trials and are in accordance with the US Food and Drug Admi... | [
"Safety",
"Immunogenicity"
] |
NCT03232567 | 4.3 | Number of Sites and Subjects | 4.3 Number of Sites and Subjects The study will be conducted at 1 site in the United States. Sixty subjects will be enrolled. | [] |
NCT03232567 | 4.4 | Duration of Subject Participation and Study | 4.4 Duration of Subject Participation and Study Each subject will participate in the study for approximately 7 months. The end of the study is defined as the last visit of the last subject participating in the study. The expected duration of the study is approximately 9 months. 05 October 2017 Confidential Page 24 of 6... | [] |
NCT03232567 | 5 | SUBJECT POPULATION | 5 SUBJECT POPULATION The Investigator must keep a record (ie, a subject screening log) of subjects who are screened for this study. | [] |
NCT03232567 | 5.1 | Inclusion Criteria | 5.1 Inclusion Criteria Subjects who meet all of the following criteria may be included in the study: - 1. Men and women 18 to 49 years of age, inclusive - 2. Good general health status as determined by the Investigator - 3. Adequate venous access for repeated phlebotomies - 4. Screening laboratory results within instit... | [] |
NCT03232567 | 5.2 | Exclusion Criteria | 5.2 Exclusion Criteria Subjects who meet any of the following criteria will be excluded from the study: - 1. Pregnant, possibly pregnant, or lactating women - 2. Household contacts of pregnant women, children 35.0 kg/m2 - 5. Positive results for HIV, hepatitis B virus, or hepatitis C virus at Screening - 6. Asthma or o... | [] |
NCT03232567 | 6 | INVESTIGATIONAL PRODUCTS | 6 INVESTIGATIONAL PRODUCTS | [] |
NCT03232567 | 6.1 | Formulation, Packaging, and Administration | 6.1 Formulation, Packaging, and Administration | [] |
NCT03232567 | 6.1.1 | NasoVAX | 6.1.1 NasoVAX NasoVAX uses the RespirVec platform developed by Altimmune for intranasally administered vaccines, an E1/E3-deleted, RD-Ad5 vector that expresses the protein of interest within respiratory epithelial cells. In the case of NasoVAX, the vector contains a genetic insert encoding the HA surface protein antige... | [] |
NCT03232567 | 6.1.2 | Placebo | 6.1.2 Placebo The placebo is normal saline provided by the investigational site. The 0.5 mL placebo doses will be administered as an intranasal spray using a 1 mL syringe fitted with a Teleflex LMA MAD Nasal Intranasal Mucosal Atomization Device and will be identical in appearance to NasoVAX doses. Further information ... | [] |
NCT03232567 | 6.2 | Labelling | 6.2 Labelling All IPs will be labelled in accordance with applicable regulatory guidelines. | [] |
NCT03232567 | 6.3 | Storage | 6.3 Storage NasoVAX will be stored in a secure place under appropriate storage conditions at -20°C ± 5°C. Normal saline will be stored in a secure place in accordance with storage conditions on the product label. | [] |
NCT03232567 | 6.4 | Blinding and Unblinding | 6.4 Blinding and Unblinding Investigators, subjects, and all study staff with direct subject contact will be blinded to assignment to NasoVAX or placebo. A designated unblinded pharmacist (or otherwise qualified person) at the site will assign the NasoVAX or placebo based on the block randomization table provided by th... | [] |
NCT03232567 | 6.5 | Randomization and Timing of NasoVAX/Placebo | 6.5 Randomization and Timing of NasoVAX/Placebo Subjects will be enrolled into 3 sequential cohorts of 20 subjects each defined by the viral particle dose (1×109 , 1×1010, or 1×1011 vp). Within each sentinel group and cohort, subjects will be randomized at a ratio of 3:1 ratio to receive 1 intranasal dose of NasoVAX or... | [] |
NCT03232567 | 6.6 | Stopping Criteria | 6.6 Stopping Criteria If any event meeting the following criteria occurs, the SRC will review all available safety information before additional patients are dosed: - Occurrence of any related SAE or Grade 4 AE - Occurrence of 2 Grade 3 AEs in the same organ system - Occurrence of the same Grade 3 laboratory abnormalit... | [] |
NCT03232567 | 6.7 | Accountability, Dispensing, and Destruction | 6.7 Accountability, Dispensing, and Destruction The Investigator (or designee) will maintain an accurate record of the receipt of each IP as shipped by the Sponsor (or designee), including the date received. In addition, an accurate IP disposition record will be kept, specifying the amount dispensed for each subject an... | [] |
NCT03232567 | 6.8 | Prior and Concomitant Treatments | 6.8 Prior and Concomitant Treatments All concomitant treatments, including over-the-counter medicines, will be recorded from 30 days before the NasoVAX/placebo dose through 28 days after the NasoVAX/placebo dose and coded using the WHO Drug Dictionary. Only immunosuppressive medication (see list in [Appendix 3](#page-6... | [] |
NCT03232567 | 6.8.1 | Prohibited Prior Medications and Vaccines | 6.8.1 Prohibited Prior Medications and Vaccines Subjects who received any of the following medications and vaccines may not be enrolled: • Corticosteroids, alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunosuppressive therapies within 90 days before Day 1 (see list in [Appendix 3... | [] |
NCT03232567 | 6.8.2 | Prohibited Concomitant Medications and Vaccines | 6.8.2 Prohibited Concomitant Medications and Vaccines The following medications and vaccines are prohibited during the study: - Statin medication from Day 1 to Day 29 (see list in Section [6.8.1](#page-29-4)) - Corticosteroids, alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunosu... | [] |
NCT03232567 | 6.9 | Contraception | 6.9 Contraception All subjects must practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization ... | [] |
NCT03232567 | 6.10 | Compliance | 6.10 Compliance All IPs will be administered by trained personnel at the investigational site. 05 October 2017 Confidential Page 31 of 66 | [] |
NCT03232567 | 7 | STUDY ASSESSMENTS AND DATA COLLECTION | 7 STUDY ASSESSMENTS AND DATA COLLECTION Refer to Section [1.2.](#page-13-0) for the Schedule of Events. | [] |
NCT03232567 | 7.1 | Demographics | 7.1 Demographics Demographic data and other baseline characteristics will be obtained and recorded at Screening. | [] |
NCT03232567 | 7.2 | Medical History | 7.2 Medical History A standard medical, medication, and surgical history will be obtained and recorded at Screening. | [] |
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