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 | 2.7.4.13 | Method of Detecting AEs and SAEs | 2.7.4.13. Method of Detecting AEs and SAEs Electronic diaries have specifically been designed for this study by the Sponsor. The eDiaries will include prelisted AEs (solicited ARs) and intensity scales; they will also include blank space for the recording of information on other AEs (unsolicited AEs) and concomitant me... | [] |
NCT05330975 | 2.7.4.14 | Follow-up of AEs and SAEs | 2.7.4.14. Follow-up of AEs and SAEs After the initial AE/SAE report, the investigator is required to proactively follow each participant at subsequent visits and contacts. All AEs and SAEs will be treated as medically appropriate and followed until resolution, stabilization, the event is otherwise explained, or the par... | [] |
NCT05330975 | 2.7.4.15 | Regulatory Reporting Requirements for SAEs | 2.7.4.15. Regulatory Reporting Requirements for SAEs - 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. - The Sponsor has a l... | [] |
NCT05330975 | 2.7.5 | Pregnancy | 2.7.5. Pregnancy Details of all pregnancies occurring in participants after the start of injection must be reported to the Sponsor or designee within 24 hours of learning of the pregnancy following the procedures outlined in Section [2.7.4.6.](#page-56-0) Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal dea... | [] |
NCT05330975 | 2.7.6 | Safety Monitoring | 2.7.6. Safety Monitoring Safety monitoring for this study will include the blinded study team members, inclusive of, at a minimum, the Sponsor's medical monitor and a CRO medical monitor, a blinded IST, and an unblinded DSMB. The study team will conduct ongoing blinded safety reviews during the study and will be respon... | [] |
NCT05330975 | 2.7.7 | Treatment of Overdose | 2.7.7. Treatment of Overdose As the study treatment is to be administered by an HCP, it is unlikely that an overdose will occur. Dose deviations will be tracked as protocol deviations (Section [6.1.8\)](#page-132-1). | [] |
NCT05330975 | 2.7.8 | Pharmacokinetics | 2.7.8. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. | [] |
NCT05330975 | 2.7.9 | Pharmacodynamics | 2.7.9. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. | [] |
NCT05330975 | 2.7.10 | Biomarkers | 2.7.10. Biomarkers Immunogenicity assessments are described in Section [2.7.2.](#page-50-1) Biomarker assessment may include genomic and transcriptomics samples. | [] |
NCT05330975 | 2.7.11 | Health Economics | 2.7.11. Health Economics Health economics are not evaluated in this study. | [] |
NCT05330975 | 2.8 | Statistical Considerations | 2.8. Statistical Considerations This section summarizes the planned statistical analysis strategy and procedures for the study. The details of statistical analysis will be provided in a statistical analysis plan (SAP), which will be finalized before the database lock for the study. If changes are made to primary and/or... | [] |
NCT05330975 | 2.8.1 | Blinding and Responsibility for Analyses | 2.8.1. Blinding and Responsibility for Analyses This is an observer-blind study. The investigator, study staff, study participants, site monitors, and Sponsor personnel (or its designees) will be blinded to the IP administered until the study database is locked and unblinded, with the following exceptions: • Unblinded ... | [] |
NCT05330975 | 2.8.1.1 | Breaking the Blind | 2.8.1.1. Breaking the Blind 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 ... | [] |
NCT05330975 | 2.8.2 | Statistical Hypotheses | 2.8.2. Statistical Hypotheses The immunogenicity primary objectives are to evaluate the effect of coadministered influenza vaccine with mRNA-1345 on the immune response to RSV-A virus and influenza A and B strains included in Afluria Quadrivalent. There are 6 co-primary endpoints to support the primary objectives.
Pri... | [
"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 Influenza:",
"Co-primary endpoints based on GMT at Da... |
NCT05330975 | 2.8.3 | Sample Size Determination | 2.8.3. Sample Size Determination The study will plan to randomize approximately 1620 participants, with approximately 420 participants receiving mRNA-1345 plus placebo (Group 1), 600 participants receiving mRNA-1345 plus Afluria Quadrivalent (Group 2), and 600 participants receiving Afluria Quadrivalent plus placebo (G... | [] |
NCT05330975 | 2.8.4 | Analysis Sets | 2.8.4. Analysis Sets The analysis sets are described in [Table](#page-66-1) 6 for Parts A and B and [Table](#page-123-3) 13for Part C. Table 6: Analysis Sets | Set | Description | |----------------|----------------------------------------------------------------| | Randomized Set | Includes all participants who are ran... | [] |
NCT05330975 | 2.8.5 | Statistical Methods | 2.8.5. Statistical Methods | [] |
NCT05330975 | 2.8.5.1 | Immunogenicity Analysis | 2.8.5.1. Immunogenicity Analysis The immunogenicity endpoints will be analyzed using the PP Set, by vaccination group. If the number of participants in the full analysis set (FAS) and PP Set differs (defined as the difference divided by the total number of participants in the PP Set) by more than 10%, supportive analys... | [] |
NCT05330975 | 2.8.5.2 | Safety Analyses | 2.8.5.2. 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, AEs leading to discontinuation, vital signs, and physical examination findings. Solicited ARs will be coded accordi... | [] |
NCT05330975 | 2.8.5.3 | Exploratory Analyses | 2.8.5.3. Exploratory Analyses Exploratory analyses not addressed in Section [2.8.5.3](#page-69-0) will be described in the SAP before database lock. | [] |
NCT05330975 | 2.8.6 | Planned Analyses | 2.8.6. Planned Analyses A primary analysis and a final analysis will be conducted in this study. Further details can be found in the SAP. | [] |
NCT05330975 | 2.8.6.1 | Primary Analysis | 2.8.6.1. Primary Analysis The primary analysis of safety and immunogenicity will be performed after all participants have completed the Day 29 Visit. All data relevant to the primary study analysis through the Day 29 visit will be cleaned and locked for the primary analysis (ie, data that are as clean as possible) and ... | [] |
NCT05330975 | 2.8.6.2 | Final Analysis | 2.8.6.2. Final Analysis The final analysis of all endpoints will be performed after all participants have completed Day 181/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 181/EoS. | [] |
NCT05330975 | 2.8.7 | Multiplicity | 2.8.7. 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 | 3 | PART B | 3. PART B Part B 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 mRNA-1273.214 in adults ≥50 years of age. | [] |
NCT05330975 | 3.1 | Protocol Summary | 3.1. Protocol Summary | [] |
NCT05330975 | 3.1.1 | Synopsis (Part B) | 3.1.1. Synopsis (Part B)
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:",
"Study details include:",
"Number of Participants:",
"Data Monitoring/other Committee:"
] |
NCT05330975 | 3.1.2 | Schema (Part B) | 3.1.2. Schema (Part B) Figure 2: Study Schema (Part B)  | [] |
NCT05330975 | 3.1.3 | SoA (Part B) | 3.1.3. SoA (Part B) Table 7: SoA (Part B) | Visit Number | Screening | 1 | 2 | 3 | 4 | 5 | 6, 7, 8 | 9 | 10 | USV | |------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------|------|-----------|------|-----... | [] |
NCT05330975 | 3.2 | Objectives and Endpoints (Part B) | 3.2. Objectives and Endpoints (Part B) The objectives and endpoints of this study are described in [Table](#page-34-1) 2. Table 8: Study Objectives and Endpoints (Part B) | Objectives | Endpoints | |----------------------------------------------------------------------------------------------------------------------|--... | [] |
NCT05330975 | 3.3 | Study Design | 3.3. Study Design | [] |
NCT05330975 | 3.3.1 | General Design (Part B) | 3.3.1. General Design (Part B) Part B 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 mRNA-1273.214 in adults ≥50 years of age. All participants will participate in a Screening pe... | [
"Safety Oversight"
] |
NCT05330975 | 3.3.2 | Scientific Rationale for Study Design | 3.3.2. 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 mRNA-1273.214 compared with either vaccine alone in medically stable older adults ≥50 years of age. Participants will receive either m... | [] |
NCT05330975 | 3.3.3 | Choice of Vaccine Dose | 3.3.3. 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). CCI CCI The -µg booster dose of mRNA-1273.214 was selected for this study based on the dose chosen for other Phase 3 mRNA-1273/1273.214 clinical studies. | [] |
NCT05330975 | 3.3.4 | EoS Definition | 3.3.4. EoS Definition A participant is considered to have completed the study if he or she has completed the last scheduled procedure on Day 211 (ie, 6 months after administration of the last IP injection on Day 29; [Table](#page-76-1) 7). The EoS is defined as completion of the last visit of the last participant in th... | [] |
NCT05330975 | 3.4 | Study Population | 3.4. Study Population Prospective approval of protocol deviations for recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT05330975 | 3.4.1 | Inclusion Criteria (Part B) | 3.4.1. Inclusion Criteria (Part B) 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 | 3.4.2 | Exclusion Criteria (Part B) | 3.4.2. Exclusion Criteria (Part B) 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 14-day Sc... | [] |
NCT05330975 | 3.4.3 | Lifestyle Restrictions | 3.4.3. Lifestyle Restrictions Not applicable. | [] |
NCT05330975 | 3.4.4 | Screen Failures | 3.4.4. Screen Failures See Section [2.4.4](#page-40-1) for details. | [] |
NCT05330975 | 3.5 | Study Treatment | 3.5. Study Treatment | [] |
NCT05330975 | 3.5.1 | Investigational Products Administered | 3.5.1. Investigational Products Administered mRNA-1345 is an LNP formulation consisting of mRNA sequences encoding the RSV fusion glycoprotein stabilized in the prefusion conformation. mRNA-1273.214 is based on the same platform as mRNA-1345. mRNA-1273.214 contains CX-024414, the mRNA that encodes for the S-2P of the W... | [] |
NCT05330975 | 3.5.2 | Randomization and Blinding | 3.5.2. Randomization and Blinding Randomization will be performed using an IRT system. Randomization is further described in Section [3.3.1.](#page-80-1) | [] |
NCT05330975 | 3.5.2.1 | Blinding | 3.5.2.1. Blinding See Section [2.5.2.1](#page-41-0) for details. | [] |
NCT05330975 | 3.5.2.2 | Unblinding | 3.5.2.2. Unblinding See Section [2.5.2.2](#page-41-1) for details. | [] |
NCT05330975 | 3.5.3 | Preparation, Handling, Storage, and Accountability | 3.5.3. Preparation, Handling, Storage, and Accountability | [] |
NCT05330975 | 3.5.3.1 | Preparation of Study Vaccine | 3.5.3.1. 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-1273.214 will be provided as a sterile liquid for injection and will be a white to off white dispersion at a concentration of mRNA-1345, mRNA-1273.214... | [] |
NCT05330975 | 3.5.3.2 | Study Vaccine Administration | 3.5.3.2. Study Vaccine Administration mRNA-1345, mRNA-1273.214, and/or placebo will be administered as IM injections, one in each deltoid muscle at the times indicated in the SoA ([Table](#page-76-1) 7), according to the procedures specified in the Pharmacy Manual. Each arm (left and right) and the corresponding vaccin... | [] |
NCT05330975 | 3.5.3.3 | Study Vaccine Delivery and Receipt | 3.5.3.3. Study Vaccine Delivery and Receipt The Sponsor (or designee) is responsible for the following: - Supplying mRNA-1345, mRNA-1273.214, 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 investigator is ... | [] |
NCT05330975 | 3.5.3.4 | Study Vaccine Packaging and Labeling | 3.5.3.4. 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 mRNA-1273.214, will be prepared, packaged, and labeled in accordance with the standard operating procedures of the Sponsor or those of its designee, CFR... | [] |
NCT05330975 | 3.5.3.5 | Study Vaccine Storage | 3.5.3.5. Study Vaccine Storage mRNA-1345 should be stored at –25 ºC to –15 ºC (–13 ºF to 5 ºF). mRNA-1273.214 must be stored at -90 °C to -60°C (-130 °F to -76 °F). mRNA-1345 and mRNA-1273.214 must be received by a designated unblinded study personnel at the study site, handled and stored safely, kept in a secure locat... | [] |
NCT05330975 | 3.5.3.6 | Study Vaccine Accountability | 3.5.3.6. Study Vaccine Accountability See Section [2.5.3.6](#page-43-0) for details. | [] |
NCT05330975 | 3.5.3.7 | Study Vaccine Handling and Disposal | 3.5.3.7. Study Vaccine Handling and Disposal See Section [2.5.3.7](#page-43-1) for details. | [] |
NCT05330975 | 3.5.4 | Study Intervention Compliance | 3.5.4. Study Intervention Compliance See Section [2.5.4](#page-43-2) for details. | [] |
NCT05330975 | 3.5.5 | Prior and Concomitant Medications | 3.5.5. Prior and Concomitant Medications | [] |
NCT05330975 | 3.5.5.1 | Prior Medications and Therapies | 3.5.5.1. 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 | 3.5.5.2 | Concomitant Medications and Therapies | 3.5.5.2. 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 | 3.5.5.3 | Concomitant Medications and Vaccines That May Lead to the Elimination of a Participant from the Per-Protocol Analyses | 3.5.5.3. 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 | 3.5.6 | Intervention After the End of the Study | 3.5.6. Intervention After the End of the Study See Section [2.5.6](#page-45-0) for details. | [] |
NCT05330975 | 3.6 | Delay or Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 3.6. Delay or Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | [] |
NCT05330975 | 3.6.1 | Criteria for Delay of Vaccine Administration | 3.6.1. Criteria for Delay of Vaccine Administration | [] |
NCT05330975 | 3.6.1.1 | Individual Participant Criteria for Delay of Study Vaccination | 3.6.1.1. Individual Participant Criteria for Delay of Study Vaccination See Section [2.6.1.1](#page-45-3) for details. | [] |
NCT05330975 | 3.6.2 | Participant Discontinuation/Withdrawal From the Study | 3.6.2. Participant Discontinuation/Withdrawal From the Study See Section [2.6.2](#page-45-4) for details. | [] |
NCT05330975 | 3.6.3 | Lost to Follow-Up | 3.6.3. Lost to Follow-Up See Section [2.6.3](#page-46-0) for details. | [] |
NCT05330975 | 3.7 | Study Assessments and Procedures | 3.7. Study Assessments and Procedures See Section [2.7](#page-47-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.1 | Safety Assessments and Procedures | 3.7.1. Safety Assessments and Procedures See Section [2.7.1](#page-48-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). In addition, for Part B, the following will be performed: Any reverse transcriptase-polymerase chain reaction–confirmed case of RSV or any positive SARS-CoV-2 testing by an auth... | [] |
NCT05330975 | 3.7.1.1 | Use of Electronic Diaries | 3.7.1.1. Use of Electronic Diaries See Section [2.7.1.1](#page-48-1) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.1.1.1 | Ancillary Supplies for Participant Use | 3.7.1.1.1 Ancillary Supplies for Participant Use See Section [2.7.1.1.1](#page-49-2) for details. | [] |
NCT05330975 | 3.7.1.2 | Safety Telephone Call | 3.7.1.2. Safety Telephone Call See Section [2.7.1.2](#page-49-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.1.3 | Vital Sign Measurements | 3.7.1.3. Vital Sign Measurements See Section [2.7.1.3](#page-49-1) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.1.4 | Physical Examinations | 3.7.1.4. Physical Examinations See Section [2.7.1.4](#page-50-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.2 | Immunogenicity Assessments | 3.7.2. Immunogenicity Assessments Blood samples for immunogenicity assessments will be collected at the time points indicated in the SoA [\(Table](#page-76-1) 7). Immunogenicity assessments will be performed for all participants. The following analytes will be measured: - RSV Abs, as measured by neutralization assay (n... | [] |
NCT05330975 | 3.7.3 | Efficacy Assessments | 3.7.3. 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 | 3.7.4 | Safety Definitions and Related Procedures | 3.7.4. Safety Definitions and Related Procedures | [] |
NCT05330975 | 3.7.4.1 | Adverse Event | 3.7.4.1. Adverse Event See Section [2.7.4.1](#page-51-2) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.2 | Serious Adverse Events | 3.7.4.2. Serious Adverse Events See Section [2.7.4.2](#page-51-3) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.3 | Solicited Adverse Reactions | 3.7.4.3. Solicited Adverse Reactions See Section [2.7.4.3](#page-52-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.4 | Medically Attended Adverse Events | 3.7.4.4. Medically Attended Adverse Events See Section [2.7.4.4](#page-54-0) for details. | [] |
NCT05330975 | 3.7.4.5 | Adverse Event of Special Interest | 3.7.4.5. Adverse Event of Special Interest See Section [2.7.4.5](#page-54-1) for details. | [] |
NCT05330975 | 3.7.4.6 | Eliciting and Documenting Adverse Events | 3.7.4.6. Eliciting and Documenting Adverse Events See Section [2.7.4.6](#page-56-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.7 | Assessment of Intensity | 3.7.4.7. Assessment of Intensity See Section [2.7.4.7](#page-56-1) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.8 | Assessment of Causality | 3.7.4.8. Assessment of Causality See Section [2.7.4.8](#page-57-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.9 | Reporting Adverse Events | 3.7.4.9. Reporting Adverse Events See Section [2.7.4.9](#page-57-1) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.10 | Reporting Serious Adverse Events | 3.7.4.10. Reporting Serious Adverse Events See Section [2.7.4.10](#page-58-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.11 | Reporting of Adverse Events of Special Interest | 3.7.4.11. 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 B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.12 | Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information | 3.7.4.12. 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 B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.13 | Method of Detecting AEs and SAEs | 3.7.4.13. Method of Detecting AEs and SAEs See Section [2.7.4.13](#page-59-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.14 | Follow-up of AEs and SAEs | 3.7.4.14. Follow-up of AEs and SAEs See Section [2.7.4.14](#page-60-0) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.4.15 | Regulatory Reporting Requirements for SAEs | 3.7.4.15. Regulatory Reporting Requirements for SAEs See Section [2.7.4.15](#page-60-1) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.5 | Pregnancy | 3.7.5. Pregnancy See Section [2.7.5](#page-60-2) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). | [] |
NCT05330975 | 3.7.6 | Safety Monitoring | 3.7.6. Safety Monitoring See Section [2.7.6](#page-60-3) for details and refer to the SoA for Part B [\(Table](#page-76-1) 7). In addition, the following will be performed for Part B because of the inclusion of mRNA-1273.214 in the study design: An independent CEAC that includes cardiologists will review suspected case... | [] |
NCT05330975 | 3.7.7 | Treatment of Overdose | 3.7.7. Treatment of Overdose See Section [2.7.7](#page-61-0) for details. | [] |
NCT05330975 | 3.7.8 | Pharmacokinetics | 3.7.8. Pharmacokinetics Pharmacokinetic parameters are not evaluated in this study. | [] |
NCT05330975 | 3.7.9 | Pharmacodynamics | 3.7.9. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. | [] |
NCT05330975 | 3.7.10 | Biomarkers | 3.7.10. Biomarkers Immunogenicity assessments are described in Section [3.7.2.](#page-90-0) Biomarker assessment may include genomic and transcriptomics samples. | [] |
NCT05330975 | 3.7.11 | Health Economics | 3.7.11. Health Economics Health economics are not evaluated in this study. | [] |
NCT05330975 | 3.8 | Statistical Considerations | 3.8. Statistical Considerations This section summarizes the planned statistical analysis strategy and procedures for the study. The details of statistical analysis will be provided in a SAP, which will be finalized before the database lock for the study. If changes are made to primary and/or secondary objectives or rel... | [] |
NCT05330975 | 3.8.1 | Statistical Methods | 3.8.1. Statistical Methods | [] |
NCT05330975 | 3.8.1.1 | Immunogenicity Analysis | 3.8.1.1. Immunogenicity Analysis The immunogenicity endpoints will be analyzed using the PP Set, by vaccination group. If the number of participants in the FAS and PP Set differs (defined as the difference divided by the total number of participants in the PP Set) by more than 10%, supportive analyses of immunogenicity... | [] |
NCT05330975 | 3.8.1.2 | Safety Analyses | 3.8.1.2. Safety Analyses See Section [2.8.5.2](#page-68-0) for details. In addition, for Part B, the following will be performed: The number and percentage of participants with any solicited local AR, solicited systemic AR, and solicited AR during the 7 day follow-up period after administration of the IP at Day 29 will... | [] |
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