protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05244421 | 2 | EVALUATION GOALS | 2. EVALUATION GOALS Please briefly describe key goals of your evaluation and what you hope to learn below. The key goal of this descriptive evaluation is to assess the extent to which participation in the Fatherhood Works Program is positively associated with improved attitudes and behaviors among low-income fathers an... | [] |
NCT05244421 | 3 | EVALUATION ENROLLMENT | 3. EVALUATION ENROLLMENT Please provide the expected start and end dates for program and evaluation enrollment using the tables below. | IMPLEMENTATION EVALUATIONPlease leave blank if not conducting an implementation study. | | | | | |-------------------------------------------------------------------------------------... | [] |
NCT05244421 | 4 | EVALUATION TIMELINE | 4. EVALUATION TIMELINE Please include a timeline for key activities of the evaluation below. | Evaluation Activity | Start Date | End Date | |-----------------------------------------------------------------------|------------|---------------------------------| | Additional evaluation staff hiring andonboarding | 1/15/... | [
"EVALUATION PLAN",
"1. RESEARCH QUESTIONS",
"1.1. OVERVIEW OF RESEARCH QUESTIONS",
"1.2. OUTCOME RESEARCH QUESTIONS",
"2. BACKGROUND",
"3. LOGIC MODEL"
] |
NCT05244421 | 4 | HYPOTHESES | 4. HYPOTHESES For each specified research question, state the hypothesized result(s) and briefly describe why these results are anticipated. | ResearchQuestion | Hypothesized Result | |----------------------|----------------------------------------------------------------------------------------------------------------... | [] |
NCT05244421 | 5 | RESEARCH DESIGN | 5. RESEARCH DESIGN For each research question, briefly describe why the research design proposed will answer each research question(s). State whether the proposed evaluation is a descriptive or impact evaluation and justify why the proposed research design is best suited to answer the research question(s). | ResearchQu... | [] |
NCT05244421 | 6 | ONGOING GRANTEE AND LOCAL EVALUATOR COORDINATION | 6. ONGOING GRANTEE AND LOCAL EVALUATOR COORDINATION Describe how the grantee and local evaluator collaboratively worked together to identify the research question(s) and research design to ensure its feasibility and relevance. Describe how the grantee and local evaluator will continue to work together throughout the ev... | [] |
NCT05244421 | 7 | LEAD STAFF | 7. LEAD STAFF Define the roles of lead staff for the evaluation from both organizations below. | Name | Organization | Role in the Evaluation | |-----------------------|------------------------------------|--------------------------------------------------------------| | Dr. Matthew Shepherd | Midwest Evaluation andRes... | [] |
NCT05244421 | 8 | SAMPLE | 8. SAMPLE | [] |
NCT05244421 | 8.1 | TARGET POPULATION(S) | 8.1. TARGET POPULATION(S) For each target population identified in Section 1.2, please describe the target population(s), and explicitly state whether the population(s) differs from those who will be broadly served by the grant. Describe how the target population will be identified. Explicitly state the unit of analysi... | [] |
NCT05244421 | 8.2 | METHODS TO PROMOTE SUFFICIENT PROGRAM PARTICIPATION | 8.2. METHODS TO PROMOTE SUFFICIENT PROGRAM PARTICIPATION Please describe methods to promote sufficient program participation in the table below. What methods will you use to ensure sufficient sample is recruited, enrolls, and participates in the program? GCT and their community partners will recruit program participant... | [] |
NCT05244421 | 9 | DATA COLLECTION | 9. DATA COLLECTION | [] |
NCT05244421 | 9.1 | CONSTRUCTS AND MEASURES | 9.1. CONSTRUCTS AND MEASURES Clearly articulate the constructs of interest, measures to evaluate those constructs, and specific data collection instruments. Provide any information on the reliability and validity of the data collection instruments. For standardized instruments, you may provide the citation for the inst... | [] |
NCT05244421 | 9.2 | CONSENT | 9.2. CONSENT Describe how and when program applicants will be informed of the study and will have the option of agreeing (i.e., consenting to) or declining to participate in the study. Because the planned evaluation involves human subjects, GCT understands program implementation requires both IRB approval and participa... | [] |
NCT05244421 | 9.3 | METHODS OF DATA COLLECTION | 9.3. METHODS OF DATA COLLECTION If the evaluation will collect multiple waves of data, describe the timing of these waves below. When describing follow-up periods, specify whether the follow-up period will be post-baseline, post-random assignment, or post-program completion. | Wave of Data Collection | Timing of Data C... | [] |
NCT05244421 | 10 | IRB/PROTECTION OF HUMAN SUBJECTS | 10.IRB/PROTECTION OF HUMAN SUBJECTS Please describe the process for protection of human subjects, and IRB review and approval of the proposed program and evaluation plans. Name the specific IRB to which you expect to apply. Solutions IRB, a private commercial Association for the Accreditation of Human Research Protecti... | [] |
NCT05244421 | 11 | DATA | 11.DATA | [] |
NCT05244421 | 11.1 | DATABASES | 11.1. DATABASES For each database used to enter data, please describe the database into which data will be entered (i.e., nFORM and/or other databases), including both performance measure data you plan to use in your local evaluation and any additional local evaluation data. Describe the process for data entry (i.e., w... | [] |
NCT05244421 | 11.2 | DATA REPORTING AND TRANSFER | 11.2. DATA REPORTING AND TRANSFER For each database provided in the table above, please indicate the ability to export individuallevel reports to an Excel or comma-delimited format and whether identifying information is available for linking to data from other sources. | Database Name | Ability to Export IndividualRepo... | [] |
NCT05244421 | 11.3 | CURRENT SECURITY AND CONFIDENTIALITY STANDARDS | 11.3. CURRENT SECURITY AND CONFIDENTIALITY STANDARDS For each database provided in Section 11.1, please Indicate the ability to be able to encrypt data access during transit (for example, accessed through an HTTPS connection); be able to encrypt data at rest (that is, when not in transit), have in place a data backup a... | [] |
NCT05299723 | 1 | Study Purpose and Rationale | 1. Study Purpose and Rationale The goal of this project is to conduct preliminary testing of a chronotherapeutic intervention targeting disturbed sleep in survivors of acute coronary syndrome (ACS). In Phase A (a single-arm open-label study), we will examine the feasibility of administering the study intervention for 1... | [
"Secondary Aim 1: Determine whether the CC intervention engages its target mechanism: sleep."
] |
NCT05299723 | 2 | Study Design | 2. Study Design To achieve these aims, we propose to enroll a total of 20 patients who have experienced an ACS event into this two-phase study. Phase A will be a single-arm open-label study of the home-based CC intervention in 5 post-ACS patients. Phase A will consist of English-speaking patients only. Phase A will pri... | [
"Overview of Phase A Study Design:",
"Screening and consent:",
"Overview of Phase B Study Design: Screening and consent:"
] |
NCT05299723 | 3 | Study Procedures | 3. Study Procedures Eligibility Criteria: A total of 20 ACS patients who report some degree of sleep disturbance (either insomnia symptoms or short sleep duration) will be offered an opportunity to enroll in the study. 5 ACS patients will be enrolled into Phase A and 15 ACS patients will be enrolled into Phase B. Patie... | [] |
NCT05299723 | 3 | Compensation | 3. Compensation Participants will be reimbursed for their time participating in the study in the form of PayCards. Phase A: Participants in Phase A will receive \$40 for successful completion of Visit 1. They will receive a second payment of \$40 for completion of Visit 2. They will receive a third payment of \$50 for ... | [] |
NCT05299723 | 4 | Risks | 4. Risks Bright light therapy (BLT): Although extremely unlikely, participants may encounter risks that any person may encounter when engaging in treatment with BLT. BLT side effects can rarely include eye strain, headache, nausea, irritability or agitation. These side-effects are expected to be mild, and to be reversi... | [] |
NCT05330975 | 1 | INTRODUCTION | 1. INTRODUCTION
This study is divided into Part A (Section [2\)](#page-27-0), Part B (Section [3\)](#page-71-0), and Part C (Section [4\)](#page-99-0). Part A is a Phase 3 randomized, observer-blind, study to evaluate safety, tolerability, and immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alon... | [
"This study is divided into Part A (Section [2\\)](#page-27-0), Part B (Section [3\\)](#page-71-0), and Part C (Section [4\\)](#page-99-0)."
] |
NCT05330975 | 1.1 | Background and Overview | 1.1. Background and Overview Lower respiratory tract infections, including pneumonia, represent a substantial burden of illness in older adults. It is estimated that lower respiratory infections caused approximately 1.27 million deaths (95% confidence interval [CI]: 1.15-1.34 million) in older adults across 195 countri... | [
"Respiratory syncytial virus",
"Influenza",
"Respiratory syndrome coronavirus 2 (SARS-CoV-2)"
] |
NCT05330975 | 1.1.1 | mRNA-1345 | 1.1.1. mRNA-1345 ModernaTX, Inc. (the Sponsor) has developed a rapid response, proprietary vaccine platform based on a messenger RNA (mRNA) delivery system. The platform is based on the principle and observations that cells in vivo can take up mRNA, translate it, and then express protein viral antigen(s) on the cell su... | [] |
NCT05330975 | 1.1.2 | Afluria® Quadrivalent Influenza Vaccine | 1.1.2. Afluria® Quadrivalent Influenza Vaccine Afluria® Quadrivalent is an egg-based, inactivated influenza vaccine indicated for active immunization against influenza disease. The vaccine will be provided to the study site in its commercial packaging, containing the recommended influenza strains for the 2021-2022 infl... | [] |
NCT05330975 | 1.1.3 | mRNA-1273.214 | 1.1.3. mRNA-1273.214 mRNA-1273.214 is based on the same platform described in Section [1.1.1.](#page-23-0) mRNA-1273.214 contains CX-024414, the mRNA that encodes for the prefusion stabilized spike glycoprotein (S-2P) of the Wuhan-Hu-1 isolate of SARS-CoV-2 and CX-031302, the mRNA that encodes for the S-2P of the SARS-... | [] |
NCT05330975 | 1.1.4 | Study Rationale | 1.1.4. Study Rationale
Part A: The Sponsor's position is that the coadministration of mRNA-1345 with a seasonal influenza vaccine will allow people to receive both vaccines at once to reduce the number of visits and add to the uptake/convenience in the elderly population that is at risk for both severe RSV and influen... | [
"Part A:",
"Part B:",
"Part C:"
] |
NCT05330975 | 1.1.5 | Nonclinical Studies | 1.1.5. Nonclinical Studies Nonclinical immunogenicity and safety studies have been completed by the Sponsor with mRNA-1345 or similar mRNA-based vaccines formulated in SM-102 (heptadecan-9-yl 8 ((2 hydroxyethyl) (6 oxo-6-(undecyloxy) hexyl) amino) octanoate), the custom manufactured lipid used in the mRNA-1345 LNP form... | [] |
NCT05330975 | 1.1.6 | Clinical Studies | 1.1.6. Clinical Studies The mRNA-1345 vaccine is currently being evaluated for safety and immunogenicity in a Phase 1 study (NCT04528719) and a Phase 2/3 study (NCT05127434). The Phase 1 study (mRNA-1345-P101) is an observer-blind, placebo-controlled, dose-escalation study of mRNA-1345 in healthy younger adults aged 18... | [] |
NCT05330975 | 1.2 | Benefit/Risk Assessment | 1.2. Benefit/Risk Assessment Summaries of the potential risks and benefits of mRNA-1345 and mRNA-1273 are provided in the most recent versions of the IBs. | [] |
NCT05330975 | 1.2.1 | Known Potential Benefits | 1.2.1. Known Potential Benefits Participants who receive mRNA-1345 may or may not directly benefit from the vaccination, as the efficacy of mRNA-1345 is yet to be established. Participants will be contributing to the process of developing a new potentially prophylactic measure in an area of unmet medical need (the prev... | [] |
NCT05330975 | 1.2.2 | Risks From Study Participation and Their Mitigation | 1.2.2. Risks From Study Participation and Their Mitigation Immediate systemic allergic reactions (eg, anaphylaxis) can occur following any vaccination. These reactions are very rare and are estimated to occur once per 450,000 vaccinations for vaccines that do not contain allergens such as gelatin or egg protein [\(Zent... | [] |
NCT05330975 | 1.2.3 | Overall Benefit/Risk Conclusion | 1.2.3. Overall Benefit/Risk Conclusion Appropriate eligibility criteria, as well as specific criteria for delaying the vaccination, are included in this protocol. The risk to participants in this study may be minimized by compliance with the eligibility criteria and study assessments and procedures. All safety findings... | [] |
NCT05330975 | 2 | PART A | 2. PART A Part A is a Phase 3 randomized, observer-blind, study to evaluate safety, tolerability, and immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or coadministered with a seasonal influenza vaccine in adults ≥50 years of age. | [] |
NCT05330975 | 2.1 | Protocol Summary | 2.1. Protocol Summary | [] |
NCT05330975 | 2.1.1 | Synopsis (Part A) | 2.1.1. Synopsis (Part A)
Protocol Title: A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered with a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given ... | [
"Protocol Title:",
"Regulatory Agency Identifier Numbers:",
"Rationale:",
"Objectives and Endpoints:",
"Overall Design:",
"Brief Summary:",
"Number of Participants:",
"Data Monitoring/other Committee:"
] |
NCT05330975 | 2.1.2 | Schema (Part A) | 2.1.2. Schema (Part A) Figure 1: Study Schema (Part A)  Abbreviation: V = visit. | [] |
NCT05330975 | 2.1.3 | SoA (Part A) | 2.1.3. SoA (Part A) Table 1: SoA (Part A) | Visit Number | Screening | 1 | 2 | 3 | 4, 5, 6, 7 | 8 | USV | |----------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------|------|----------|---------------------... | [] |
NCT05330975 | 2.2 | Objectives and Endpoints (Part A) | 2.2. Objectives and Endpoints (Part A) The objectives and endpoints of this study are described in [Table](#page-34-1) 2. Table 2: Study Objectives and Endpoints (Part A) | Objectives | Endpoints | |-------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05330975 | 2.3 | Study Design | 2.3. Study Design | [] |
NCT05330975 | 2.3.1 | General Design (Part A) | 2.3.1. General Design (Part A) This is a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and immunogenicity of mRNA-1345, an mRNA vaccine targeting RSV, when given alone or coadministered with a seasonal influenza vaccine (Afluria Quadrivalent) in adults ≥50 years of age. All participant... | [] |
NCT05330975 | 2.3.2 | Scientific Rationale for Study Design | 2.3.2. Scientific Rationale for Study Design This study is designed as a randomized, observer-blind study to evaluate the safety and immunogenicity of mRNA-1345 when coadministered with a commercial influenza vaccine (Afluria Quadrivalent) compared with either vaccine alone in medically stable older adults ≥50 years of... | [] |
NCT05330975 | 2.3.3 | Choice of Vaccine Dose | 2.3.3. Choice of Vaccine Dose The -µg dose of mRNA-1345 was selected for this study based on the mRNA-1345-P101 study data (Section [1.1.6\)](#page-24-1). | [] |
NCT05330975 | 2.3.4 | EoS Definition | 2.3.4. EoS Definition A participant is considered to have completed the study if he or she has completed the last scheduled procedure on Day 181 (ie, 6 months after administration of the investigational product (IP) on Day 1; [Table](#page-32-1) 1). The EoS is defined as completion of the last visit of the last partici... | [] |
NCT05330975 | 2.4 | Study Population (Part A) | 2.4. Study Population (Part A) Prospective approval of protocol deviations for recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT05330975 | 2.4.1 | Inclusion Criteria (Part A) | 2.4.1. Inclusion Criteria (Part A) Participants are eligible to be included in the study only if all the following criteria apply: - 1. Adults ≥50 years of age on the day of the Randomization Visit who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medi... | [] |
NCT05330975 | 2.4.2 | Exclusion Criteria (Part A) | 2.4.2. Exclusion Criteria (Part A) Participants are not eligible to be included in the study if any of the following criteria apply: - 1. Participant is acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior to or at Day 1. Participants meeting this criterion may be rescheduled within the 14day Scr... | [] |
NCT05330975 | 2.4.3 | Lifestyle Restrictions | 2.4.3. Lifestyle Restrictions Not applicable. | [] |
NCT05330975 | 2.4.4 | Screen Failures | 2.4.4. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently assigned to treatment. A minimum set of screen failure information is required to ensure transparent reporting of screen failures to meet the Consolidated Standards of Reporting T... | [] |
NCT05330975 | 2.5 | Study Treatment | 2.5. Study Treatment | [] |
NCT05330975 | 2.5.1 | Investigational Products Administered | 2.5.1. Investigational Products Administered mRNA-1345 is an LNP formulation consisting of mRNA sequences encoding the RSV fusion glycoprotein stabilized in the prefusion conformation. Afluria Quadrivalent is an egg-based, inactivated influenza vaccine. The placebo is 0.9% sodium chloride (normal saline) injection, US ... | [] |
NCT05330975 | 2.5.2 | Randomization and Blinding | 2.5.2. Randomization and Blinding Randomization will be performed using an interactive response technology (IRT) system. Randomization is further described in Section [2.3.1.](#page-35-1) | [] |
NCT05330975 | 2.5.2.1 | Blinding | 2.5.2.1. Blinding The study is observer-blind, such that only designated unblinded study personnel responsible for vaccine preparation, administration, and/or accountability will have access to study treatment assignments. Neither the participant, investigator, nor clinical staff responsible for study assessments/safet... | [] |
NCT05330975 | 2.5.2.2 | Unblinding | 2.5.2.2. Unblinding Except in the case of medical necessity, a participant's vaccine assignment should not be unblinded without the approval of the Sponsor. If a participant becomes seriously ill or pregnant during the study, the blind will be broken only if knowledge of the vaccine assignment will affect that particip... | [] |
NCT05330975 | 2.5.3 | Preparation, Handling, Storage, and Accountability | 2.5.3. Preparation, Handling, Storage, and Accountability | [] |
NCT05330975 | 2.5.3.1 | Preparation of Study Vaccine | 2.5.3.1. Preparation of Study Vaccine mRNA-1345 will be provided as a sterile liquid for injection and will be a white to off white dispersion at a concentration of Afluria Quadrivalent will be provided as a 0.5 mL, single-dose, pre-filled syringe. mRNA-1345 and placebo preparation instructions are detailed in the Phar... | [] |
NCT05330975 | 2.5.3.2 | Study Vaccine Administration | 2.5.3.2. Study Vaccine Administration mRNA-1345, Afluria Quadrivalent, and/or placebo will be administered as IM injections, one in each deltoid muscle on Day 1, according to the procedures specified in the Pharmacy Manual. Each arm (left and right) and the corresponding vaccine or placebo administered will be recorded... | [] |
NCT05330975 | 2.5.3.3 | Study Vaccine Delivery and Receipt | 2.5.3.3. Study Vaccine Delivery and Receipt The Sponsor (or designee) is responsible for the following: - Supplying mRNA-1345, Afluria Quadrivalent, and placebo (0.9% sodium chloride) to the study sites. - Confirming the appropriate labeling of the IP, so it complies with the legal requirements of the US. The investiga... | [] |
NCT05330975 | 2.5.3.4 | Study Vaccine Packaging and Labeling | 2.5.3.4. Study Vaccine Packaging and Labeling The Sponsor will provide the investigator (via the study site pharmacy) with adequate quantities of the IP. mRNA-1345 and Afluria Quadrivalent will be prepared, packaged, and labeled in accordance with the standard operating procedures of the Sponsor or those of its designe... | [] |
NCT05330975 | 2.5.3.5 | Study Vaccine Storage | 2.5.3.5. Study Vaccine Storage mRNA-1345 should be stored at –25 to –15 ºC (–13 to 5 ºF). mRNA-1345 must be received by a designated unblinded study personnel at the study site, handled and stored safely, kept in a secure location with restricted access (unblinded study personnel only), and protected from moisture and ... | [] |
NCT05330975 | 2.5.3.6 | Study Vaccine Accountability | 2.5.3.6. Study Vaccine Accountability It is the investigator's responsibility that the IP accountability study staff maintain accurate records in an IP accountability log of receipt of all IP, study site IP inventory, IP dispensing, IP injections, and return to the Sponsor or alternative disposition of used and unused ... | [] |
NCT05330975 | 2.5.3.7 | Study Vaccine Handling and Disposal | 2.5.3.7. Study Vaccine Handling and Disposal An unblinded study site monitor will reconcile the IP inventory during the conduct of the study and at the EoS for compliance. Once fully reconciled at the site at the EoS, the IP can be destroyed on-site, if study site procedures allow, or returned to a destruction depot pe... | [] |
NCT05330975 | 2.5.4 | Study Intervention Compliance | 2.5.4. Study Intervention Compliance The IP will be administered at the study site under direct observation of medically qualified unblinded study personnel and appropriately recorded (date and time) in the source documents and eCRF. The qualified unblinded study personnel will confirm that the participant has received... | [] |
NCT05330975 | 2.5.5 | Prior and Concomitant Medications | 2.5.5. Prior and Concomitant Medications | [] |
NCT05330975 | 2.5.5.1 | Prior Medications and Therapies | 2.5.5.1. Prior Medications and Therapies Information about prior medications (including any prescription or over-the-counter medications, vaccines, or blood products) taken by the participant within the 28 days before providing informed consent (or as designated in the inclusion/exclusion requirements) will be recorded... | [] |
NCT05330975 | 2.5.5.2 | Concomitant Medications and Therapies | 2.5.5.2. Concomitant Medications and Therapies At the study site, the study staff must question the participant regarding any medications taken and nonstudy vaccinations received by the participant and record the following information in the eCRF: - All nonstudy vaccinations administered within the period starting 28 d... | [] |
NCT05330975 | 2.5.5.3 | Concomitant Medications and Vaccines That May Lead to the Elimination of a Participant from the Per-Protocol Analyses | 2.5.5.3. Concomitant Medications and Vaccines That May Lead to the Elimination of a Participant from the Per-Protocol Analyses The use of the following concomitant medications and/or vaccines will not require withdrawal of the participant from the study but may determine a participant's evaluability in the per-protocol... | [] |
NCT05330975 | 2.5.6 | Intervention After the End of the Study | 2.5.6. Intervention After the End of the Study IP will not be available to the participants following the end of the study. | [] |
NCT05330975 | 2.6 | Delay or Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 2.6. Delay or Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | [] |
NCT05330975 | 2.6.1 | Criteria for Delay of Vaccine Administration | 2.6.1. Criteria for Delay of Vaccine Administration | [] |
NCT05330975 | 2.6.1.1 | Individual Participant Criteria for Delay of Study Vaccination | 2.6.1.1. Individual Participant Criteria for Delay of Study Vaccination Body temperature must be measured before vaccination. The following events constitute criteria for delay of injection, and if either of these events occur at the time scheduled for dosing, the participant may be injected at a later date within the ... | [] |
NCT05330975 | 2.6.2 | Participant Discontinuation/Withdrawal from the Study | 2.6.2. Participant Discontinuation/Withdrawal from the Study Participants who withdraw or are withdrawn from the study will not be replaced. A "withdrawal" from the study refers to a situation wherein a participant does not return for the final visit planned in the protocol. Participants can withdraw consent and withdr... | [] |
NCT05330975 | 2.6.3 | Lost to Follow-Up | 2.6.3. Lost to Follow-Up A participant will be considered LTFU if he or she repeatedly fails to return for scheduled visits without stating an intention to withdraw consent and is unable to be contacted by the study site. The following actions must be taken if a participant fails to return to the clinic for a required ... | [] |
NCT05330975 | 2.7 | Study Assessments and Procedures | 2.7. Study Assessments and Procedures Before performing any study procedures, all potential participants will sign an informed consent form (ICF; Section [6.1.6\)](#page-131-2). Participants will undergo study procedures at the time points specified in the SoA [\(Table](#page-32-1) 1 [Part A], [Table](#page-76-1) 7 [Pa... | [] |
NCT05330975 | 2.7.1 | Safety Assessments and Procedures | 2.7.1. Safety Assessments and Procedures Safety assessments will include monitoring and recording of the following for each participant, according to the SoA [\(Table](#page-32-1) 1 [Part A], [Table](#page-76-1) 7 [Part B], or [Table](#page-104-1) 11 [Part C]): - • Solicited local and systemic ARs (Section [2.7.4.3\)](... | [] |
NCT05330975 | 2.7.1.1 | Use of Electronic Diaries | 2.7.1.1. Use of Electronic Diaries At the time of consent, the participants must confirm they will be willing to complete an eDiary using either an application downloaded to their smartphone or a device that will be provided at the time of enrollment. Before enrollment on Day 1, the participant will be instructed to do... | [] |
NCT05330975 | 2.7.1.1.1 | Ancillary Supplies for Participant Use | 2.7.1.1.1 Ancillary Supplies for Participant Use The study sites will distribute Sponsor-provided oral thermometers and rulers for use by participants to assess body temperature and injection site reactions, respectively, for recording solicited ARs in the eDiaries. Based on availability, smartphone devices may be prov... | [] |
NCT05330975 | 2.7.1.2 | Safety Telephone Call | 2.7.1.2. Safety Telephone Call The safety telephone call will be made to the participants by trained study site personnel. This call will follow a Sponsor-approved script, which will facilitate the collection of relevant safety information. Safety telephone calls by the study site to each participant will occur at the ... | [] |
NCT05330975 | 2.7.1.3 | Vital Sign Measurements | 2.7.1.3. Vital Sign Measurements Vital sign measurements include systolic and diastolic blood pressure, heart rate, respiratory rate, and body temperature (preferred route is oral). The participant will be seated for at least 5 minutes before all measurements are taken. Vital signs will be measured at the time points i... | [] |
NCT05330975 | 2.7.1.4 | Physical Examinations | 2.7.1.4. Physical Examinations A full physical examination, including height and weight, will be performed at the Screening Visit [\(Table](#page-32-1) 1 [Part A], [Table](#page-76-1) 7 [Part B], or [Table](#page-104-1) 11 [Part C]). The full physical examination will include an assessment of the skin, head, ears, eyes... | [] |
NCT05330975 | 2.7.2 | Immunogenicity Assessments | 2.7.2. Immunogenicity Assessments Blood samples for immunogenicity assessments will be collected at the time points indicated in the SoA [\(Table](#page-32-1) 1). Immunogenicity assessments will be performed for all participants. The following analytes will be measured: - RSV Abs, as measured by nAbs and binding (bAbs)... | [] |
NCT05330975 | 2.7.3 | Efficacy Assessments | 2.7.3. Efficacy Assessments While the study will not be powered for efficacy assessments, symptoms of infection with respiratory pathogens will be tracked as an exploratory objective in this study. | [] |
NCT05330975 | 2.7.4 | Safety Definitions and Related Procedures | 2.7.4. Safety Definitions and Related Procedures | [] |
NCT05330975 | 2.7.4.1 | Adverse Event | 2.7.4.1. Adverse Event An AE is defined as any untoward medical occurrence associated with the use of an IP in humans, whether or not considered related to the IP.
Events Meeting the Adverse Event Definition: - Exacerbation of a chronic or intermittent preexisting condition, including an increase in the frequency and/... | [
"Events Meeting the Adverse Event Definition:",
"Events NOT Meeting the Adverse Event Definition:"
] |
NCT05330975 | 2.7.4.2 | Serious Adverse Events | 2.7.4.2. Serious Adverse Events An AE (including an AR) is considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes:
• Death A death that occurs during the study or that comes to the attention of the investigator during the protocol-defined follow-up period m... | [
"• Death",
"• Is life-threatening",
"• Inpatient hospitalization or prolongation of existing hospitalization In general, inpatient hospitalization indicates the participant was admitted to the hospital or emergency ward for at least one overnight stay for observation and/or treatment that would not have been ap... |
NCT05330975 | 2.7.4.3 | Solicited Adverse Reactions | 2.7.4.3. Solicited Adverse Reactions The term "reactogenicity" refers to the occurrence and intensity of selected signs and symptoms (ARs) occurring after administration of the IP. The eDiary will solicit daily participant reporting of ARs using a structured checklist (Section [2.7.1.1\)](#page-48-1). Participants will... | [] |
NCT05330975 | 2.7.4.4 | Medically Attended Adverse Events | 2.7.4.4. Medically Attended Adverse Events An MAAE is an AE that leads to an unscheduled visit to an HCP, including telephone calls. This would include visits to a study site for unscheduled assessments (eg, rash assessment) and visits to HCPs external to the study site (eg, urgent care, primary care physician). The in... | [] |
NCT05330975 | 2.7.4.5 | Adverse Event of Special Interest | 2.7.4.5. Adverse Event of Special Interest An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor is required and documentation is in the form of a case narrative. ... | [] |
NCT05330975 | 2.7.4.5.1 | Anaphylaxis | 2.7.4.5.1 Anaphylaxis All suspected cases of anaphylaxis should be recorded as MAAEs and reported as an SAE, based on the criteria for a medically important event, unless the event meets other serious criteria. As an SAE, the event should be reported to the Sponsor (or designee) immediately and in all circumstances wit... | [] |
NCT05330975 | 2.7.4.5.2 | Myocarditis/Pericarditis | 2.7.4.5.2 Myocarditis/Pericarditis A case of suspected, probable, or confirmed myocarditis, pericarditis, or myopericarditis should be reported as an AESI, even if it does not meet the criteria per the CDC case definition. The event should also be reported as an SAE if it meets seriousness criteria (Section [2.7.4.2](#... | [] |
NCT05330975 | 2.7.4.6 | Eliciting and Documenting Adverse Events | 2.7.4.6. Eliciting and Documenting Adverse Events The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF and reported to the Sponsor. Solicited ARs will be collected from the day of injection and 6 subsequent days. Other (unsolicited) AEs will be collected from the day of injection ... | [] |
NCT05330975 | 2.7.4.7 | Assessment of Intensity | 2.7.4.7. Assessment of Intensity An event is defined as "serious" when it meets at least one of the predefined criteria as described in the definition of an SAE (Section [2.7.4.2\)](#page-51-3), NOT when it is rated as severe. The severity (or intensity) of an AR or AE refers to the extent to which it affects the parti... | [] |
NCT05330975 | 2.7.4.8 | Assessment of Causality | 2.7.4.8. Assessment of Causality The investigator's assessment of an AE's relationship to IP is part of the documentation process but is not a factor in determining what is or is not reported in the study. The investigator will assess the causality (ie, whether there is a reasonable possibility that the IP caused the e... | [] |
NCT05330975 | 2.7.4.9 | Reporting Adverse Events | 2.7.4.9. Reporting Adverse Events The investigator is responsible for reporting all AEs that are observed or reported during the study, regardless of their relationship to IP or their clinical significance. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. All unsolicite... | [] |
NCT05330975 | 2.7.4.10 | Reporting Serious Adverse Events | 2.7.4.10. Reporting Serious Adverse Events Prompt notification by the investigator to the Sponsor of an SAE is essential so that legal obligations and ethical responsibilities toward the safety of participants and the safety of a study intervention under clinical investigation are met. Any AE considered serious by the ... | [] |
NCT05330975 | 2.7.4.11 | Reporting of Adverse Events of Special Interest | 2.7.4.11. Reporting of Adverse Events of Special Interest The following process for reporting an AESI ensures compliance with 21 CFR 312 and ICH GCP guidelines. After learning that a participant has experienced an AESI, the investigator (or designee) is responsible for reporting the AESI to the Sponsor, regardless of i... | [] |
NCT05330975 | 2.7.4.12 | Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information | 2.7.4.12. Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information Medical occurrences that begin before administration of the IP but after obtaining informed consent will be recorded in the "Medical History/Current Medical Conditions" section of the eCRF and not in the AE section; h... | [] |
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