protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03232567 | 7.3 | Reactogenicity (Diary) | 7.3 Reactogenicity (Diary) Each subject will be provided with a diary and a thermometer after each dose. The subjects will record and provide severity grade (except for temperature) for the following items in a diary (sample provided in [Appendix 2\)](#page-58-0) and whether any medication or treatment was used for the... | [] |
NCT03232567 | 7.4 | Adverse Events (Including Medically Attended Events, Serious Adverse Events, and New-onset Chronic Illnesses) | 7.4 Adverse Events (Including Medically Attended Events, Serious Adverse Events, and New-onset Chronic Illnesses) See Section [9.](#page-38-0) | [] |
NCT03232567 | 7.5 | Height and Weight | 7.5 Height and Weight Height and weight will be measured and recorded at Screening. | [] |
NCT03232567 | 7.6 | Complete Physical Examination | 7.6 Complete Physical Examination Examination of the following systems will be performed at the time points specified in the Schedule of Events and as clinically indicated: cardiovascular; dermatological; head, eyes, ear, 05 October 2017 Confidential Page 32 of 66 nose, and throat; extremities; gastrointestinal; muscul... | [] |
NCT03232567 | 7.7 | Targeted and Symptom-driven Physical Examination | 7.7 Targeted and Symptom-driven Physical Examination Examination of the respiratory and head, eyes, ear, nose, and throat systems and any additional systems as indicated by signs or symptoms reported by the subject will be performed at the time points specified in the Schedule of Events and as clinically indicated. An ... | [] |
NCT03232567 | 7.8 | Vital Signs | 7.8 Vital Signs At the time points specified in the Schedule of Events and before any blood sample collection, systolic and diastolic blood pressure and pulse will be measured and recorded using a semiautomatic recording device with an appropriate cuff size after the subject has been in a supine position for at least 5... | [] |
NCT03232567 | 7.9 | Electrocardiogram | 7.9 Electrocardiogram At the time points specified in the Schedule of Events and before any blood sample collection, a 12-lead ECG will be performed after the subject has been in a supine position for at least 5 minutes. Interpretation (normal, abnormal not clinically significant, abnormal clinically significant) will ... | [] |
NCT03232567 | 7.10 | Blood Samples | 7.10 Blood Samples | [] |
NCT03232567 | 7.10.1 | Safety Laboratory Tests | 7.10.1 Safety Laboratory Tests Samples for the following tests will be collected, processed, and shipped to the laboratory in accordance with instructions in the laboratory manual at the time points specified in the Schedule of Events: - Hematology: hemoglobin, platelet count, white blood cell count with differential (... | [] |
NCT03232567 | 7.10.2 | Serum Samples (Immunogenicity) | 7.10.2 Serum Samples (Immunogenicity) Serum samples will be collected and processed at the time points specified in the Schedule of Events. Collection, processing, labelling, storage and shipping instructions for these samples are provided in the laboratory manual. Influenza virus HAI assay against A/California/04/2009... | [] |
NCT03232567 | 7.10.3 | Peripheral Blood Mononuclear Cells (Immunogenicity) | 7.10.3 Peripheral Blood Mononuclear Cells (Immunogenicity) Whole blood samples will be collected and processed to isolate PBMCs at the time points specified in the Schedule of Events. Collection, processing, labelling, storage, and shipping instructions for these samples are provided in the laboratory manual. ELISpot w... | [] |
NCT03232567 | 7.11 | Pregnancy Tests | 7.11 Pregnancy Tests A serum or urine sample will be collected from all women who have not been surgically sterilized or have laboratory confirmation of postmenopausal status and tested at the time points specified in the Schedule of Events. | [] |
NCT03232567 | 7.12 | Nasopharyngeal Swabs | 7.12 Nasopharyngeal Swabs A nasopharyngeal swab sample will be collected and processed at the time points specified in the Schedule of Events. Collection, processing, labelling, storage, and shipping instructions for these samples are provided in the laboratory manual. Nasopharyngeal swabs are not obtained on the day o... | [] |
NCT03232567 | 7.13 | Viral Culture | 7.13 Viral Culture A sample (as clinically indicated) for viral culture will be collected from any subject who experiences acute symptoms compatible with possible adenoviral infection within 28 days after the NasoVAX/placebo dose. The sample will be collected, processed, and shipped to the laboratory in accordance with... | [] |
NCT03232567 | 8 | STUDY VISITS | 8 STUDY VISITS | [] |
NCT03232567 | 8.1 | Screening (Within 28 Days Before Day 1) | 8.1 Screening (Within 28 Days Before Day 1) The subject will be screened to assess eligibility criteria. The following assessments and procedures will be performed: - Written informed consent - Demographics - Medical history - Concomitant medications (including vaccines) recording - Complete physical examination - Heig... | [] |
NCT03232567 | 8.2 | Dosing Period | 8.2 Dosing Period If at any time in the Dosing Period (Days 1 to 29) the subject experiences acute symptoms compatible with adenoviral infection, a sample for viral culture will be collected. | [] |
NCT03232567 | 8.2.1 | Day 1 | 8.2.1 Day 1 The following procedures will be performed before NasoVAX/placebo administration: - Concomitant medications (including vaccines) recording - AE assessment - Complete physical examination - Vital signs - Drug and alcohol screen - Urine pregnancy test - Sample collection: - o Serum for humoral response (inclu... | [] |
NCT03232567 | 8.2.2 | Day 2 (Telephone Contact) | 8.2.2 Day 2 (Telephone Contact) The following procedures will be performed: - Review of diary - Concomitant medications (including vaccines) recording - AE assessment | [] |
NCT03232567 | 8.2.3 | Day 4 (± 1 Day) | 8.2.3 Day 4 (± 1 Day) The following procedures will be performed: - Review of diary - Targeted and symptom-driven physical examination - Vitals signs - Concomitant medications (including vaccines) recording - AE assessment 05 October 2017 Confidential Page 36 of 66 - • Sample collection: - o Serum for humoral response ... | [] |
NCT03232567 | 8.2.4 | Day 8 (± 1 Day) | 8.2.4 Day 8 (± 1 Day) The following procedures will be performed: - Review of diary - Targeted and symptom-driven physical examination - Vitals signs - Concomitant medications (including vaccines) recording - AE assessment - Sample collection: - o Clinical laboratory tests (hematology, serum chemistry, urinalysis) - o ... | [] |
NCT03232567 | 8.2.5 | Day 15 (± 1 Day) | 8.2.5 Day 15 (± 1 Day) The following procedures will be performed: - Review of diary - Targeted and symptom-driven physical examination - Vitals signs - Concomitant medications (including vaccines) recording - AE assessment - Sample collection: - o Serum for humoral response - o Nasopharyngeal swab | [] |
NCT03232567 | 8.2.6 | Day 29 (± 3 Days) | 8.2.6 Day 29 (± 3 Days) The following procedures will be performed: - Targeted and symptom-driven physical examination - Vitals signs - Concomitant medications (including vaccines) recording 05 October 2017 Confidential Page 37 of 66 - AE assessment - Urine pregnancy test - ECG - Sample collection: - o Clinical laborat... | [] |
NCT03232567 | 8.3 | Follow-up Period | 8.3 Follow-up Period | [] |
NCT03232567 | 8.3.1 | Day 91 (± 10 Days) | 8.3.1 Day 91 (± 10 Days) The following procedures will be performed: - Recording of immunosuppressive medications (see list in [Appendix 3\)](#page-64-1) and vaccines - Assessment of SAEs, MAEs, and NCIs - Sample collection: - o Serum for humoral response - o Nasopharyngeal swab | [] |
NCT03232567 | 8.3.2 | Day 181 (± 10 Days) | 8.3.2 Day 181 (± 10 Days) The following procedures will be performed: - Recording of immunosuppressive medications (see list in [Appendix 3\)](#page-64-1) and vaccines - Assessment of SAEs, MAEs, and NCIs - Sample collection: - o Serum for humoral response | [] |
NCT03232567 | 9 | ADVERSE EVENTS | 9 ADVERSE EVENTS | [] |
NCT03232567 | 9.1 | Definitions | 9.1 Definitions | [] |
NCT03232567 | 9.1.1 | Adverse Event | 9.1.1 Adverse Event An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory fi... | [] |
NCT03232567 | 9.1.2 | Medically Attended Adverse Event | 9.1.2 Medically Attended Adverse Event An MAE is an AE resulting in hospitalization, emergency room visit, or visit to or from medical personnel (other than routine health care visits). | [] |
NCT03232567 | 9.1.3 | New-onset Chronic Illness | 9.1.3 New-onset Chronic Illness An NCI is an AE that is new (ie, not present at baseline) and typically chronic. The eCRF will provide a field in which the Investigator will indicate whether or not the AE recorded is an NCI. Because of the significance of this designation for the subject's health and for evaluation of ... | [] |
NCT03232567 | 9.1.4 | Serious Adverse Event | 9.1.4 Serious Adverse Event An AE or suspected adverse reaction is considered serious (an SAE) if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: - Death - Life-threatening (An AE is considered life-threatening if, in the view of either the Investigator or Sponsor, its o... | [] |
NCT03232567 | 9.2 | Reporting Responsibilities and Periods | 9.2 Reporting Responsibilities and Periods It is the responsibility of the Investigator or Subinvestigator(s) to perform periodic assessment of AEs. AEs spontaneously reported by the subject or reported in response to an open question from the study personnel (eg, 'Have you had any health problems since the previous vi... | [] |
NCT03232567 | 9.3 | Recording of Adverse Events | 9.3 Recording of Adverse Events An AE should be recorded individually in the study subject's own words (verbatim) unless, in the opinion of the Investigator, clarification of the subject's verbatim language is necessary or the AEs constitute components of a recognized condition, disease, or syndrome. In the latter case... | [] |
NCT03232567 | 9.4 | Assessment of Adverse Events | 9.4 Assessment of Adverse Events | [] |
NCT03232567 | 9.4.1 | Severity | 9.4.1 Severity The Investigator will grade severity of AEs in accordance with Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials ([Appendix 1](#page-55-0)). If an appropriate listing is not present in this table for an AE, the AE will be graded as follows: ... | [] |
NCT03232567 | 9.4.2 | Relatedness (Causality) | 9.4.2 Relatedness (Causality) The Investigator will assess causality (relationship to NasoVAX/placebo) of AEs as follows: - Related Reasons to consider an AE related to treatment may include, but are not limited, to the following: - o Timing of the event relative to the administration of the IP - o Location of the AE r... | [] |
NCT03232567 | 9.5 | Clinical Laboratory, Physical Examination, Electrocardiogram and Vital Sign Abnormalities | 9.5 Clinical Laboratory, Physical Examination, Electrocardiogram and Vital Sign Abnormalities Any abnormal laboratory result, physical examination finding, ECG interpretation, or vital sign measurement considered clinically significant by the Investigator will be recorded as an AE. A clinically significant laboratory a... | [] |
NCT03232567 | 9.6 | Pregnancy | 9.6 Pregnancy Pregnancy itself is not regarded as an AE unless there is a suspicion that the IP may have interfered with the effectiveness of a contraceptive medication. Pregnancy in a subject's partner is not considered an AE. Congenital abnormalities/birth defects and spontaneous miscarriages should be reported and h... | [] |
NCT03232567 | 9.7 | Reporting of Serious Adverse Events | 9.7 Reporting of Serious Adverse Events SAEs must be reported to the Sponsor or designee within 1 business day of becoming aware of the event. If at the time the Investigator initially reports an SAE, the event has not resolved, the Investigator must provide a follow-up report as soon as it resolves (or upon receipt of... | [] |
NCT03232567 | 9.8 | Follow-Up of Adverse Events | 9.8 Follow-Up of Adverse Events A subject who experiences any AE, whether serious or not serious, will be monitored at appropriate intervals and receive appropriate treatment and medical supervision as clinically indicated. All AEs must be followed until resolution/stabilization or until a time that is mutually agreed ... | [] |
NCT03232567 | 10 | PREGNANCY | 10 PREGNANCY The ICF will include information regarding reporting of pregnancy to the Sponsor and collection of information through the end of pregnancy that occurs in either a female subject or in a female partner of a male subject. If a female partner becomes pregnant, the Investigator will request consent from the p... | [] |
NCT03232567 | 11 | SUBJECT AND STUDY DISCONTINUATION | 11 SUBJECT AND STUDY DISCONTINUATION | [] |
NCT03232567 | 11.1 | Subject Withdrawal from the Study | 11.1 Subject Withdrawal from the Study Subjects may be withdrawn from the study at any time for the following reasons: - Withdrawal of consent - Noncompliance with study requirements - Loss to follow-up - Death - Investigator discretion - Sponsor request - Termination of the study by the Sponsor (see Section 11.3). Sub... | [] |
NCT03232567 | 11.2 | Procedures for Subjects Who Terminate the Study Early | 11.2 Procedures for Subjects Who Terminate the Study Early Any subject who prematurely discontinues the study should be followed-up for at least 28 days after the last dose of any IP. If a subject prematurely discontinues the study on or before Day 29, then the procedures listed for Day 29 visit (Section [8.2.6\)](#pag... | [] |
NCT03232567 | 11.3 | Study Discontinuation | 11.3 Study Discontinuation The entire study may be discontinued by the Sponsor for reasons including, but not limited to, the following: - An unexpected, significant, or unacceptable risk to the subjects enrolled in the study - Lack of evaluable or complete data - Decision to modify the NasoVAX development plan or to s... | [] |
NCT03232567 | 12 | STATISTICAL METHODS | 12 STATISTICAL METHODS This section includes a brief description of the statistical analyses that will be performed in this study. A detailed statistical analysis plan (SAP) will be written and finalized before database snapshot for the interim analysis. Any deviation from the SAP will be described in the Clinical Stud... | [] |
NCT03232567 | 12.1 | Analysis Populations | 12.1 Analysis Populations The following analysis populations will be used: - Safety Population: All subjects who provide informed consent, are randomized, and receive at least 1 dose of IP. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received. - ITT Populat... | [] |
NCT03232567 | 12.2 | Analysis Conventions | 12.2 Analysis Conventions For all data analyses and summary tabulations, categories for analysis and presentation are the NasoVAX and placebo groups. Baseline is defined as the last nonmissing measurement prior to the administration of IP. Continuous variables will be presented by geometric means and 95% CIs for the im... | [] |
NCT03232567 | 12.3 | Subject Disposition | 12.3 Subject Disposition The number and percentage of subjects enrolled in the study, completing the study, and discontinuing the study will be presented in a tabular format. Reasons for discontinuation will also be summarized. Listings of randomized subjects who did not receive the IP and of subjects with other import... | [] |
NCT03232567 | 12.4 | Demographic and Bassline Characteristics | 12.4 Demographic and Bassline Characteristics Demographic parameters and other baseline characteristics (age, gender, race, ethnicity, body mass index) will be summarized by dose group for all subjects in the Safety Population. | [] |
NCT03232567 | 12.5 | Prior and Concomitant Medications | 12.5 Prior and Concomitant Medications Prior and concomitant medications will be summarized by WHO Drug Dictionary anatomical therapeutic chemical level 3 and preferred term. | [] |
NCT03232567 | 12.6 | Exposure | 12.6 Exposure All IP doses will be summarized. | [] |
NCT03232567 | 12.7 | Safety Analyses | 12.7 Safety Analyses The primary endpoint for evaluation of the safety profile is the number and percentage (95% CI) of subjects with solicited and unsolicited AEs recorded postvaccination. Safety analyses will be performed using the Safety Population. | [] |
NCT03232567 | 12.7.1 | Primary Endpoints | 12.7.1 Primary Endpoints
Reactogenicity The number (percentage, 95% CI) of subjects with local reactions and systemic events will be summarized by dose group and overall. Reactogenicity events will also be summarized by severity.
Adverse Events The number (percentage, 95% CI) of subjects with AEs from Day 1 to Day 29... | [
"Reactogenicity",
"Adverse Events"
] |
NCT03232567 | 12.7.2 | Clinical Laboratory Tests and Vital Signs | 12.7.2 Clinical Laboratory Tests and Vital Signs Summary statistics for continuous parameters will be presented by dose group as follows: prevaccination, postvaccination, and change from prevaccination to postvaccination assessment. The number and percentage of subjects with postvaccination clinical laboratory values o... | [] |
NCT03232567 | 12.7.3 | Electrocardiograms | 12.7.3 Electrocardiograms Summaries of the number and percentage of subjects with normal, abnormal not clinically significant, and abnormal clinically significant interpretations will be presented. | [] |
NCT03232567 | 12.7.4 | Shedding of Replication-deficient Vector | 12.7.4 Shedding of Replication-deficient Vector Data will be summarized by count and percent positive by time point, along with median copy number. | [] |
NCT03232567 | 12.7.5 | Laboratory-confirmed Adenovirus Infection | 12.7.5 Laboratory-confirmed Adenovirus Infection Viral culture results will be listed. | [] |
NCT03232567 | 12.8 | Immunogenicity Analyses | 12.8 Immunogenicity Analyses Immunology analyses will be conducted using the ITT and PP Populations with primary conclusions drawn from the PP Population. Analyses based on the ITT Population will be undertaken and presented only if >5% of subjects in any 1 dose group were excluded from the PP Population. No imputation... | [] |
NCT03232567 | 12.8.1 | Secondary Endpoints (Humoral Immune Response) | 12.8.1 Secondary Endpoints (Humoral Immune Response) The primary variable of interest for assessment of humoral immune response to the NasoVAX antigen is homologous HAI antibody titer. The following HAI immunogenicity measures and their 95% CIs will be summarized by dose group: - GMT at baseline and postvaccination on ... | [] |
NCT03232567 | 12.8.2 | Exploratory Endpoints | 12.8.2 Exploratory Endpoints
Humoral Immune Response Humoral immune response (antibody level measured by microneutralization in serum) will be summarized by GMT at baseline and postvaccination on Day 29 and responder rate (the proportion of subjects with 2-fold and 4-fold rise since baseline) (95% CI) on Day 29.
Cell... | [
"Humoral Immune Response",
"Cellular Immune Response",
"Mucosal Immune Response",
"Humoral Immune Response to Nonrepresented Influenza Strains",
"Effect of Predose Adenovirus Serotype 5 Serum Antibody Levels on Immunogenicity",
"Comparison to Licensed Seasonal Influenza Vaccine"
] |
NCT03232567 | 12.9 | Sample Size and Power | 12.9 Sample Size and Power The sample size for this study was selected as adequate and reasonable for an initial review of the safety and immunogenicity profile of the NasoVAX at doses to be well tolerated by young adults, rather than for statistical power. The sample size will permit initial estimates of reactogenicit... | [] |
NCT03232567 | 12.10 | Interim and Final Analyses | 12.10 Interim and Final Analyses One interim analysis of humoral immunogenicity data and safety data (including summaries of AE, reactogenicity, concomitant medications and vaccines, vital signs, ECG, and laboratory data and listing of any viral culture results) will be conducted when all data through the Day 29 visit ... | [] |
NCT03232567 | 13 | ETHICAL, LEGAL, AND ADMINISTRATIVE ISSUES | 13 ETHICAL, LEGAL, AND ADMINISTRATIVE ISSUES The procedures set out in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the Sponsor and the Investigator abide by Good Clinical Practice (GCP) as described in International Council for Harmonisation (... | [] |
NCT03232567 | 13.1 | Institutional Review Board Approval | 13.1 Institutional Review Board Approval The protocol, the ICF, any advertisement, or any other written information provided to the subject will be reviewed and approved by the Institutional Review Board (IRB). The Sponsor will supply relevant material for the Investigator to submit to the IRB for the study's review an... | [] |
NCT03232567 | 13.2 | Informed Consent | 13.2 Informed Consent The Investigator (or designee) will explain the nature of the study to each subject. The subjects will be informed that participation is voluntary and that they can withdraw from the study at any time. After the study has been fully explained, each subject will provide written informed consent to ... | [] |
NCT03232567 | 13.3 | Biological Samples | 13.3 Biological Samples Biological samples collected for this study will become the property of the Sponsor and may be used for future research conducted by or on behalf of the Sponsor or its affiliates, partners, or collaborators. No identifiable personal information will be associated with these blood samples. Any sa... | [] |
NCT03232567 | 13.4 | Confidentiality | 13.4 Confidentiality Personal study subject data collected and processed for the purposes of this study will be managed by the Investigator and the investigational site staff with adequate precautions to ensure the confidentiality of these data, and in accordance with applicable laws and regulations on personal data pr... | [] |
NCT03232567 | 13.5 | Protocol Compliance | 13.5 Protocol Compliance The Investigator should conduct the trial in compliance with the approved protocol. The Investigator must not make any changes to the study without Sponsor and IRB approval except when necessary to eliminate apparent immediate hazards to the subjects. A protocol change intended to eliminate an ... | [] |
NCT03232567 | 13.6 | Protocol Amendments | 13.6 Protocol Amendments Any significant change in the study requires a protocol amendment. All protocol amendments must be reviewed and approved by the Sponsor, the Investigator, and the IRB before implementation. | [] |
NCT03232567 | 13.7 | Publication and Disclosure Policy | 13.7 Publication and Disclosure Policy All information provided regarding the study, as well as all information collected or documented during the course of the study, will be regarded as confidential. The Investigator agrees not to disclose such information in any way without prior written permission from the Sponsor.... | [] |
NCT03232567 | 13.8 | Clinical Study Report | 13.8 Clinical Study Report A final CSR will be prepared in accordance with the ICH guideline on structure and contents of CSRs and any applicable regulatory and legal requirements. | [] |
NCT03232567 | 13.9 | Financing and Insurance | 13.9 Financing and Insurance Financing and insurance will be addressed in a separate clinical trial agreement. 05 October 2017 Confidential Page 51 of 66 | [] |
NCT03232567 | 14 | STUDY DATA AND RECORDS | 14 STUDY DATA AND RECORDS | [] |
NCT03232567 | 14.1 | Direct Access | 14.1 Direct Access The Investigator will grant direct access to the monitors, auditors, and other authorized representatives of the Sponsor; the IRB approving this research; and any applicable Regulatory Authorities to the study subjects' original medical records for verification of clinical trial conduct and data. | [] |
NCT03232567 | 14.2 | Source Documents | 14.2 Source Documents Source documents are defined as the original documents (or certified copies) of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. All source documents produced in this study will be maintained by the Investigator ... | [] |
NCT03232567 | 14.3 | Case Report Forms | 14.3 Case Report Forms An electronic case report form (eCRF) will be used to record all subject data specified by this protocol into an electronic data capture (EDC) system. It is the responsibility of the Investigator to ensure the subject data are entered in an accurate and timely manner. | [] |
NCT03232567 | 14.4 | Study Monitoring | 14.4 Study Monitoring Before the start of the study, the Sponsor's monitor will meet with the Investigator and appropriate investigational site staff for training on the protocol requirements and procedures. Throughout the course of the study, the Sponsor's monitor will conduct site visits to verify that the rights and... | [] |
NCT03232567 | 14.5 | Data Management | 14.5 Data Management The study data will be using an EDC system. The Investigator and study site staff will receive system training and support. All protocol-required information collected during the study must be entered by the Investigator or designated representative in the eCRF. All data entries, modifications, or ... | [] |
NCT03232567 | 14.6 | Retention of Records | 14.6 Retention of Records ICH-GCP requires that documents be retained until at least 2 years after the last approval of a marketing application in an ICH region and there are no pending or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the formal discontinuation of cli... | [] |
NCT03232567 | 15 | REFERENCES | 15 REFERENCES Adenoviruses. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/adenovirus/about/symptoms.html. Updated April 20, 2015. Accessed June 9, 2017. Centers for Disease Control and Prevention. Estimates of deaths associated with seasonal influenza—United States, 1976-2007. MMWR Morb Morta... | [] |
NCT03232567 | 16 | APPENDICES | 16 APPENDICES
Appendix 1 Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials | Vital Signs | Mild | Moderate | Severe | Potentially Life-threatening | |------------------------------------------|------------------------------------|-------------------------... | [
"Appendix 1 Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials",
"Appendix 2 Sample Subject Diary",
"PROTOCOL NUMBER: ALT-103-201",
"SUBJECT DIARY",
"Influenza Vaccine, Intranasal (NasoVAX)",
"SUBJECT DIARY",
"DIARY INSTRUCTION",
"details ... |
NCT03283735 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY | [] |
NCT03283735 | 1.1 | SYNOPSIS | 1.1 SYNOPSIS Title: Deprescribing: a portrait and out-comes of the reduction of Polypharmacy in Portugal (DePil17-20) Study Description: This study protocol comprises three phases. The first two phases will be nationwide and aim to evaluate the prevalence and patterns of polypharmacy and assess the barriers and facilit... | [] |
NCT03283735 | 1.2 | SCHEMA | 1.2 SCHEMA
Prior to Enrollment Visit 1 Day 0 Visit 2 Day 90±7 Visit 3 Day 180 Total 380: Obtain informed consent. Screen potential participants by inclusion and exclusion criteria. Perform baseline assessments. Collect socio-demographic and clinical characteristics and medication. Evaluate the perception of medication... | [
"Prior to Enrollment Visit 1 Day 0 Visit 2 Day 90±7 Visit 3 Day 180 Total 380: Obtain informed consent. Screen potential participants by inclusion and exclusion criteria. Perform baseline assessments. Collect socio-demographic and clinical characteristics and medication. Evaluate the perception of medication with P... |
NCT03283735 | 2 | INTRODUCTION | 2 INTRODUCTION Polypharmacy is defined as the simultaneous taking of five or more drugs. It's present in 30-70% of older adults (1) and it's a significant predictor of the risk of falls (2) and other iatrogenic complications (3), inappropriate prescriptions (4), reduced patient's adherence (5), drug interactions (6), h... | [] |
NCT03283735 | 3 | OBJECTIVES AND ENDPOINTS | 3 OBJECTIVES AND ENDPOINTS Primary objective is to assess the enablement of older adults while being Deprescribed in the rise of Willingness to be Deprescribed. Secondary objective is to assess the enablement of older adults while being Deprescribed in the rise of their Quality of Life outcome. | [] |
NCT03283735 | 4 | STUDY DESIGN | 4 STUDY DESIGN This is a three-phase study: - 1. Cross-sectional, analytical study of the prevalence and patterns of polipharmacy, namely sociodemographic and clinical profiles (age, genre, area of residence and years of study) and about medication (number of drugs and their active component), in older adults attending... | [
"Phase I: prevalence of polypharmacy in older adults attending primary care in Portugal",
"Design",
"Setting",
"Sample size",
"Study procedures",
"Data collection",
"Objectives",
"Design",
"Setting",
"Sample size",
"Study procedures",
"Data collection",
"Phase III: impact of enablement of ol... |
NCT03283735 | 5 | STUDY POPULATION | 5 STUDY POPULATION Older adult (≥65 years) patients attending to the primary care consultation in Portugal. Exclusion criteria: Being acutely unwell in the last three weeks, and refuse to participate. | [] |
NCT03283735 | 6 | STUDY INTERVENTION | 6 STUDY INTERVENTION In the intervention group we will give enablement tools and talks with their GPs about how to issue the problem of polypharmacy. | [] |
NCT03283735 | 7 | STUDY ASSESSMENTS AND PROCEDURES | 7 STUDY ASSESSMENTS AND PROCEDURES | [] |
NCT03283735 | 7.1 | EFFICACY ASSESSMENTS | 7.1 EFFICACY ASSESSMENTS List and description of the procedures/evaluations to be used: - Portuguese Beliefs about Medicines Questionnaire - o For evaluation of the perception of medication - EuroQol Five Dimensions Questionnaire - o For assessment of the quality of life - Two open-questions (one to assess the facilita... | [] |
NCT03283735 | 7.2 | ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS | 7.2 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS No adverse events are expected to occur. | [] |
NCT03283735 | 8 | STATISTICAL CONSIDERATIONS | 8 STATISTICAL CONSIDERATIONS | [] |
NCT03283735 | 8.1 | STATISTICAL HYPOTHESES | 8.1 STATISTICAL HYPOTHESES The investigators' hypothesis is that the intervention will result in statistical higher willingness to be deprescribed and better quality of life. | [] |
NCT03283735 | 8.2 | SAMPLE SIZE DETERMINATION | 8.2 SAMPLE SIZE DETERMINATION According to the older adults population in the Centre of Portugal and with a 95% confidence interval and a maximum precision error of 5%, so a minimum of 380 patients should be recruited. | [] |
NCT03283735 | 8.3 | STATISTICAL ANALYSES | 8.3 STATISTICAL ANALYSES Descriptive statistics will be computed for all variables together with 95% CI whenever relevant and applicable. Associations between qualitative-independent variables will be tested using χ2 test. Comparisons between two or more independent groups regarding a quantitative variable are to be co... | [] |
NCT03283735 | 9 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 9 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] |
NCT03283735 | 9.1 | REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS | 9.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS | [] |
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