protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05330975 | 3.8.1.3 | Exploratory Analyses | 3.8.1.3. Exploratory Analyses See Section [2.8.5.3](#page-69-0) for details. | [] |
NCT05330975 | 3.8.2 | Blinding and Responsibility for Analyses | 3.8.2. Blinding and Responsibility for Analyses See Section [2.8.1](#page-61-6) for details. | [] |
NCT05330975 | 3.8.2.1 | Breaking the Blind | 3.8.2.1. Breaking the Blind See Section [2.8.1.1](#page-62-0) for details. | [] |
NCT05330975 | 3.8.3 | Statistical Hypotheses | 3.8.3. Statistical Hypotheses The immunogenicity primary objectives are to evaluate the effect of coadministered mRNA-1273.214 with mRNA-1345 on the immune response to RSV-A virus, and SARS-CoV-2 Wuhan-Hu-1 and B.1.1.529 strains. There are 6 co-primary endpoints to support the primary objectives.
Primary Objective to ... | [
"Primary Objective to Evaluate the Impact on the Immune Response to RSV-A:",
"Co-primary endpoints based on GMT at Day 29:",
"Co-primary endpoints based on Seroresponse Rate at Day 29:",
"Primary Objective to Evaluate the Impact on the Immune Response to SARS-CoV-2:",
"Co-primary endpoints based on GMC at D... |
NCT05330975 | 3.8.4 | Sample Size Determination | 3.8.4. Sample Size Determination The study will plan to randomize approximately 1680 participants, with approximately 560 participants receiving mRNA-1345 plus placebo at Day 1 and receiving mRNA-1273.214 at Day 29 (Group 4), 560 participants receiving mRNA-1345 plus mRNA-1273.214 at Day 1 and receiving placebo at Day ... | [] |
NCT05330975 | 3.8.5 | Analysis Sets | 3.8.5. Analysis Sets See Section [2.8.4](#page-66-0) for details. | [] |
NCT05330975 | 3.8.6 | Planned Analyses | 3.8.6. Planned Analyses A primary analysis and a final analysis will be conducted in this study. Further details can be found in the SAP. | [] |
NCT05330975 | 3.8.6.1 | Primary Analysis | 3.8.6.1. Primary Analysis See Section [2.8.6.1](#page-69-2) for details. | [] |
NCT05330975 | 3.8.6.2 | Final Analysis | 3.8.6.2. Final Analysis The final analysis of all endpoints will be performed after all participants have completed Day 211/EoS. Results of this analysis will be presented in a final CSR. The final CSR will include full analyses of all safety and immunogenicity data through Day 209/EoS. | [] |
NCT05330975 | 3.8.7 | Multiplicity | 3.8.7. Multiplicity A sequential/hierarchical testing procedure will be used to control the overall Type 1 error rate at 0.05 (2 sided) over the primary endpoints, key secondary efficacy endpoints, and selected secondary endpoints. The co-primary endpoints will be tested at the planned primary analysis at a 2-sided Typ... | [] |
NCT05330975 | 4 | PART C | 4. PART C Part C is a Phase 3 single arm, open-label study to evaluate safety, tolerability, and immunogenicity of a booster dose (BD) of mRNA-1345 given at 1 year following a primary dose in adults ≥50 years of age. | [] |
NCT05330975 | 4.1 | Protocol Summary | 4.1. Protocol Summary | [] |
NCT05330975 | 4.1.1 | Synopsis (Part C) | 4.1.1. Synopsis (Part C)
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 | 4.1.2 | Schema (Part C) | 4.1.2. Schema (Part C) Figure 3: Study Schema (Part C)  Abbreviations: BD = booster dose, d = days, V = visit. | [] |
NCT05330975 | 4.1.3 | SoA (Part C) | 4.1.3. SoA (Part C) Table 11: SoA (Part C) | Visit Number | Screening | 1 | 2 | 3 | 4, 5, 6, 7 | 8 | 9 | 10 | 11 | USV | |-----------------------------------------------------------------------------------|------------|----------|-----------|--------|-------------------------|---------|---------|------------|----------... | [] |
NCT05330975 | 4.2 | Objectives and Endpoints (Part C) | 4.2. Objectives and Endpoints (Part C) The objectives and endpoints of this study are described in [Table](#page-107-1) 12. Table 12: Study Objectives and Endpoints (Part C) | Objectives | Endpoints | |----------------------------------------------------------------------------------------------------------------------... | [] |
NCT05330975 | 4.3 | Study Design | 4.3. Study Design | [] |
NCT05330975 | 4.3.1 | General Design (Part C) | 4.3.1. General Design (Part C) Part C is a Phase 3 single arm, open-label, study to evaluate safety, tolerability, and immunogenicity of a BD of mRNA-1345 given at 1 year following a primary dose in adults ≥50 years of age. Participants will be selected from Part B (Groups 4 and 5) of mRNA-1345-P302. All participants w... | [] |
NCT05330975 | 4.3.2 | Scientific Rationale for Study Design | 4.3.2. Scientific Rationale for Study Design This study is designed as a single arm, open-label study to evaluate safety, tolerability, and immunogenicity of a BD of mRNA-1345 in adults ≥50 years of age who have previously received a primary dose of mRNA-1345. The mRNA-1345 recipients in the PP set in Part B (Group 4 [... | [] |
NCT05330975 | 4.3.3 | Choice of Vaccine Dose | 4.3.3. 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 | 4.3.4 | EoS Definition | 4.3.4. EoS Definition A participant is considered to have completed the study if they have completed the last scheduled procedure on BD Day 361 (ie, 12 months after administration of mRNA-1345 on BD Day 1; [Table](#page-104-1) 11). The EoS is defined as completion of the last visit of the last participant in the study ... | [] |
NCT05330975 | 4.4 | Study Population (Part C) | 4.4. Study Population (Part C) Approximately 500 participants will be enrolled. Note: Enrolled means participant agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not... | [] |
NCT05330975 | 4.4.1 | Inclusion Criteria (Part C) | 4.4.1. Inclusion Criteria (Part C) Participants are eligible to be included in the study only if all the following criteria apply: - 1. Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of this study; have immunogenicity blood sampling at Part B baseline and Day 29; completed the Day ... | [] |
NCT05330975 | 4.4.2 | Exclusion Criteria (Part C) | 4.4.2. Exclusion Criteria (Part C) Participants are not eligible to be included in the study if any of the following criteria apply: - 1. Participation in another interventional clinical research study where participant has received any IP (drug/biologic/device) within 6 months before the planned date of the BD Day 1 s... | [] |
NCT05330975 | 4.4.3 | Lifestyle Restrictions | 4.4.3. Lifestyle Restrictions Not applicable. | [] |
NCT05330975 | 4.4.4 | Screen Failures | 4.4.4. Screen Failures See Section [2.4.4](#page-40-1) for details. | [] |
NCT05330975 | 4.5 | Study Treatment | 4.5. Study Treatment | [] |
NCT05330975 | 4.5.1 | Investigational Products Administered | 4.5.1. Investigational Products Administered mRNA-1345 is an LNP-encapsulated mRNA-based vaccine consisting of mRNA encoding the RSV fusion glycoprotein stabilized in the prefusion conformation. | [] |
NCT05330975 | 4.5.2 | Randomization and Blinding | 4.5.2. Randomization and Blinding Not applicable. | [] |
NCT05330975 | 4.5.2.1 | Blinding | 4.5.2.1. Blinding Not applicable. | [] |
NCT05330975 | 4.5.2.2 | Unblinding | 4.5.2.2. Unblinding Not applicable. | [] |
NCT05330975 | 4.5.3 | Preparation, Handling, Storage, and Accountability | 4.5.3. Preparation, Handling, Storage, and Accountability | [] |
NCT05330975 | 4.5.3.1 | Preparation of Study Vaccine | 4.5.3.1. 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 mRNA-1345 preparation instructions is detailed in the Pharmacy Manual. | [] |
NCT05330975 | 4.5.3.2 | Study Vaccine Administration | 4.5.3.2. Study Vaccine Administration mRNA-1345 will be administered as one IM injection on BD Day 1 in the deltoid muscle, according to the procedures specified in the Pharmacy Manual. The arm (left or right) in which the injection is administered will be recorded by the site staff. On BD Day 1, participants will be m... | [] |
NCT05330975 | 4.5.3.3 | Study Vaccine Delivery and Receipt | 4.5.3.3. Study Vaccine Delivery and Receipt The Sponsor (or designee) is responsible for the following: - Supplying mRNA-1345 to the study sites. - Confirming the appropriate labeling of the IP so it complies with the legal requirements of the US. The investigator is responsible for acknowledging the receipt of the IP ... | [] |
NCT05330975 | 4.5.3.4 | Study Vaccine Packaging and Labeling | 4.5.3.4. Study Vaccine Packaging and Labeling The Sponsor will provide the Investigator (via the study site pharmacy) with adequate quantities of the IP. mRNA-1345 will be prepared, packaged, and labeled in accordance with the standard operating procedures of the Sponsor or those of its designee, CFR Title 21, Good Man... | [] |
NCT05330975 | 4.5.3.5 | Study Vaccine Storage | 4.5.3.5. Study Vaccine Storage mRNA-1345 should be stored at –25ºC to –15ºC (–13ºF to 5ºF). mRNA-1345 must be received by a designated study personnel at the study site, handled and stored safely, kept in a secure location with restricted access, and protected from moisture and light until it is prepared for administra... | [] |
NCT05330975 | 4.5.3.6 | Study Vaccine Accountability | 4.5.3.6. 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 | 4.5.3.7 | Study Vaccine Handling and Disposal | 4.5.3.7. Study Vaccine Handling and Disposal The 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 per instruc... | [] |
NCT05330975 | 4.5.4 | Study Intervention Compliance | 4.5.4. Study Intervention Compliance The IP will be administered at the study site under direct observation of medically qualified study personnel and appropriately recorded (date and time) in the source documents and eCRF. The qualified study personnel will confirm that the participant has received the entire dose of ... | [] |
NCT05330975 | 4.5.5 | Prior and Concomitant Medications | 4.5.5. Prior and Concomitant Medications | [] |
NCT05330975 | 4.5.5.1 | Prior Medications and Therapies | 4.5.5.1. 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 | 4.5.5.2 | Concomitant Medications and Therapies | 4.5.5.2. 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 | 4.5.5.3 | Concomitant Medications and Vaccines That May Lead to the Elimination of a Participant from the Per-Protocol Analyses | 4.5.5.3. Concomitant Medications and Vaccines That May Lead to the Elimination of a Participant from the Per-Protocol Analyses See Section [2.5.5.3](#page-44-0) for details. | [] |
NCT05330975 | 4.5.6 | Intervention After the End of the Study | 4.5.6. Intervention After the End of the Study See Section [2.5.6](#page-45-0) for details. | [] |
NCT05330975 | 4.6 | Delay or Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 4.6. Delay or Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | [] |
NCT05330975 | 4.6.1 | Criteria for Delay of Vaccine Administration | 4.6.1. Criteria for Delay of Vaccine Administration | [] |
NCT05330975 | 4.6.1.1 | Individual Participant Criteria for Delay of Study Vaccination | 4.6.1.1. Individual Participant Criteria for Delay of Study Vaccination See Section [2.6.1.1](#page-45-3) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.6.2 | Participant Discontinuation/Withdrawal from the Study | 4.6.2. Participant Discontinuation/Withdrawal from the Study See Section [2.6.2](#page-45-4) for details. | [] |
NCT05330975 | 4.6.3 | Lost to Follow-Up | 4.6.3. Lost to Follow-Up See Section [2.6.3](#page-46-0) for details. | [] |
NCT05330975 | 4.7 | Study Assessments and Procedures | 4.7. Study Assessments and Procedures See Section [2.7](#page-47-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.1 | Safety Assessments and Procedures | 4.7.1. Safety Assessments and Procedures Safety assessments will include monitoring and recording of the following for each participant, according to the SoA [\(Table](#page-104-1) 11 [Part C]): - Solicited local and systemic ARs (Section [2.7.4.3\)](#page-52-0) that occur during the 7 days following vaccine administra... | [] |
NCT05330975 | 4.7.1.1 | Use of Electronic Diaries | 4.7.1.1. Use of Electronic Diaries At the time of consent, the participants must confirm they will be willing to complete an eDiary (for 7-day reactogenicity) using either an application downloaded to their smartphone or a device that will be provided at the time of enrollment. If the participant is unable to complete ... | [] |
NCT05330975 | 4.7.1.1.1 | Ancillary Supplies for Participant Use | 4.7.1.1.1 Ancillary Supplies for Participant Use See Section [2.7.1.1.1](#page-49-2) for details. | [] |
NCT05330975 | 4.7.1.2 | Safety Telephone Call | 4.7.1.2. 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 | 4.7.1.3 | Vital Sign Measurements | 4.7.1.3. Vital Sign Measurements See Section [2.7.1.3](#page-49-1) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.1.4 | Physical Examinations | 4.7.1.4. Physical Examinations See Section [2.7.1.4](#page-50-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.2 | Immunogenicity Assessments | 4.7.2. Immunogenicity Assessments Blood samples for immunogenicity assessments will be collected at the timepoints indicated in the SoA [\(Table](#page-104-1) 11). Immunogenicity assessments will be performed for all participants. The following analytes will be measured: • RSV-A and RSV-B nAbs measured by microneutrali... | [] |
NCT05330975 | 4.7.3 | Efficacy Assessments | 4.7.3. Efficacy Assessments Not applicable. | [] |
NCT05330975 | 4.7.4 | Safety Definitions and Related Procedures | 4.7.4. Safety Definitions and Related Procedures | [] |
NCT05330975 | 4.7.4.1 | Adverse Event | 4.7.4.1. Adverse Event See Section [2.7.4.1](#page-51-2) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.2 | Serious Adverse Events | 4.7.4.2. Serious Adverse Events See Section [2.7.4.2](#page-51-3) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.3 | Solicited Adverse Reactions | 4.7.4.3. Solicited Adverse Reactions See Section [2.7.4.3](#page-52-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.4 | Medically Attended Adverse Events | 4.7.4.4. Medically Attended Adverse Events See Section [2.7.4.4](#page-54-0) for details. | [] |
NCT05330975 | 4.7.4.5 | Adverse Event of Special Interest | 4.7.4.5. Adverse Event of Special Interest See Section [2.7.4.5](#page-54-1) for details. Investigators should report events listed in Table 14, Section [6.3.1](#page-139-1) as an AESI for Part C. | [] |
NCT05330975 | 4.7.4.6 | Eliciting and Documenting Adverse Events | 4.7.4.6. Eliciting and Documenting Adverse Events See Section [2.7.4.6](#page-56-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.7 | Assessment of Intensity | 4.7.4.7. Assessment of Intensity See Section [2.7.4.7](#page-56-1) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.8 | Assessment of Causality | 4.7.4.8. Assessment of Causality See Section [2.7.4.8](#page-57-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.9 | Reporting Adverse Events | 4.7.4.9. Reporting Adverse Events See Section [2.7.4.9](#page-57-1) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.10 | Reporting Serious Adverse Events | 4.7.4.10. Reporting Serious Adverse Events See Section [2.7.4.10](#page-58-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.11 | Reporting of Adverse Events of Special Interest | 4.7.4.11. Reporting of Adverse Events of Special Interest See Section [2.7.4.11](#page-58-1) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.12 | Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information | 4.7.4.12. Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information See Section [2.7.4.12](#page-58-2) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.13 | Method of Detecting AEs and SAEs | 4.7.4.13. Method of Detecting AEs and SAEs See Section [2.7.4.13](#page-59-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.14 | Follow-up of AEs and SAEs | 4.7.4.14. Follow-up of AEs and SAEs See Section [2.7.4.14](#page-60-0) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.4.15 | Regulatory Reporting Requirements for SAEs | 4.7.4.15. Regulatory Reporting Requirements for SAEs See Section [2.7.4.15](#page-60-1) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.5 | Pregnancy | 4.7.5. Pregnancy See Section [2.7.5](#page-60-2) for details and refer to the SoA for Part C [\(Table](#page-104-1) 11). | [] |
NCT05330975 | 4.7.6 | Safety Monitoring | 4.7.6. Safety Monitoring Safety monitoring for this study will include study team members inclusive of, at a minimum, the Sponsor's Medical Monitor and Safety Physician and a CRO Medical Monitor. The study team will conduct ongoing safety reviews during the study. | [] |
NCT05330975 | 4.7.7 | Treatment of Overdose | 4.7.7. Treatment of Overdose See Section [2.7.7](#page-61-0) for details. | [] |
NCT05330975 | 4.7.8 | Pharmacokinetics | 4.7.8. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. | [] |
NCT05330975 | 4.7.9 | Pharmacodynamics | 4.7.9. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. | [] |
NCT05330975 | 4.7.10 | Biomarkers | 4.7.10. Biomarkers Immunogenicity assessments are described in Section [4.7.2.](#page-119-0) Biomarker assessment may include genomics and transcriptomics samples. | [] |
NCT05330975 | 4.7.11 | Health Economics | 4.7.11. Health Economics Health economics are not evaluated in this study. | [] |
NCT05330975 | 4.8 | Statistical Considerations | 4.8. Statistical Considerations This section summarizes the planned statistical analysis strategy and procedures for the study. The details of statistical analysis will be provided in the SAP which will be finalized before the database lock for the study. If changes are made to primary and/or secondary objectives or re... | [] |
NCT05330975 | 4.8.1 | Blinding and Responsibility for Analyses | 4.8.1. Blinding and Responsibility for Analyses Not applicable. | [] |
NCT05330975 | 4.8.1.1 | Breaking the Blind | 4.8.1.1. Breaking the Blind Not applicable. | [] |
NCT05330975 | 4.8.2 | Statistical Hypotheses | 4.8.2. Statistical Hypotheses The immunogenicity primary objectives are to evaluate the effect of a BD of mRNA-1345 on the immune response to RSV-A and RSV-B virus. There are 2 co-primary endpoints, based on GMT at BD Day 29, to support the primary objectives. The null hypothesis 0 1 : immunogenicity response to a BD o... | [] |
NCT05330975 | 4.8.3 | Sample Size Determination | 4.8.3. Sample Size Determination If there are 500 participants, Part C will have approximately 99% and 92% probability to observe at least 1 participant with an AE at a true 1% and 0.5% AE rate, respectively. If there are 450 participants, Part C will have approximately 99% and 90% probability to observe at least 1 par... | [] |
NCT05330975 | 4.8.4 | Analysis Sets | 4.8.4. Analysis Sets The analysis sets are described in [Table](#page-123-3) 13. Table 13: Analysis Sets for Part C | Set | Description | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05330975 | 4.8.5 | Statistical Methods | 4.8.5. Statistical Methods | [] |
NCT05330975 | 4.8.5.1 | Immunogenicity Analysis | 4.8.5.1. Immunogenicity Analysis Unless otherwise specified immunogenicity analysis for Part C will be based on the Part C PP Set. The primary immune endpoints based on RSV-A nAbs at BD Day 29 will be presented by descriptive summary statistics, such as median, minimum, maximum, and 95% CI for GMT. GMR will also be est... | [] |
NCT05330975 | 4.8.5.2 | Safety Analyses | 4.8.5.2. Safety Analyses Safety and reactogenicity will be assessed by clinical review of all relevant parameters, including solicited ARs (local and systemic events), unsolicited AEs, SAEs, AESIs, MAAEs, severe AEs, AEs leading to discontinuation, vital signs, and physical examination findings. Solicited ARs will be c... | [] |
NCT05330975 | 4.8.5.3 | Exploratory Analyses | 4.8.5.3. Exploratory Analyses The exploratory analyses may be conducted after database lock and will be described in the SAP. | [] |
NCT05330975 | 4.8.6 | Planned Analyses | 4.8.6. Planned Analyses One primary analysis and one final analysis will be conducted in this Part of the study. Further details can be found in the SAP. | [] |
NCT05330975 | 4.8.6.1 | Primary Analysis | 4.8.6.1. Primary Analysis The primary analysis of immunogenicity and safety will be performed after all Part C participants have completed the BD Day 29 Visit. All data relevant to the primary analysis through the BD Day 29 visit in all participants will be cleaned (ie, data that are as clean as possible) and a report ... | [] |
NCT05330975 | 4.8.6.2 | Final Analysis | 4.8.6.2. Final Analysis The final analysis of all endpoints will be performed after all participants have completed EoS visit. Results of this analysis will be presented in a final CSR. The final CSR will include full analyses of all safety and immunogenicity data through EoS. | [] |
NCT05330975 | 4.8.7 | Multiplicity | 4.8.7. Multiplicity The co-primary endpoints will be tested at the planned primary analysis at a 2-sided Type 1 error rate of 0.05. The success criteria of both co-primary endpoints need to be met in order to declare this part of the study a success to achieve noninferiority of a BD. | [] |
NCT05330975 | 5 | REFERENCES | 5. REFERENCES Aretz HT, Billingham ME, Edwards WD, Factor SM, Fallon JT, Fenoglio JJ Jr, et al. Myocarditis. A histopathologic definition and classification. Am J Cardiovasc Pathol. 1987;1(1):3-14. Bartoszko J, Loeb M. The burden of influenza in older adults: meeting the challenge. Aging Clin Exp Res. 2021;33(3):711-7.... | [] |
NCT05330975 | 6 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 6. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] |
NCT05330975 | 6.1 | APPENDIX 1: Study Governance Considerations | 6.1. APPENDIX 1: Study Governance Considerations | [] |
NCT05330975 | 6.1.1 | Regulatory and Ethical Considerations | 6.1.1. Regulatory and Ethical Considerations This study will be conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethic... | [] |
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