NCT05572658已完成不适用
mRNA-1345-P901 Study: RSV Outcomes Study Extension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,994
- 试验地点
- 106
- 主要终点
- Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV
研究概览
简要总结
The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine.
详细描述
This study will evaluate real-world data (RWD) and data from eligible United States (US) based participants from Study mRNA-1345-P301 (NCT05127434) for additional health and economic outcomes such as hospitalizations, healthcare resource utilization, disease exacerbations, and costs, associated with usage of the mRNA-1345 vaccine. The results from the current study (mRNA-1345-P901) are intended to complement the results from the mRNA-1345-P301 study. No interventions will be administered during the current study (mRNA-1345-P901).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •P901 inclusion criteria:
- •Must be a participant in P301
- •Must be based in the US
- •Must provide informed consent for P901
- •P301 key inclusion criteria:
- •Adults who are primarily responsible for self-care and activities of daily living.
- •Participants may have one or more chronic medical diagnoses (specifically chronic heart failure and chronic obstructive pulmonary disease) but should be medically stable in the opinion of the investigator.
- •Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2.
排除标准
- •P901 exclusion criteria:
- •Receipt of any future licensed RSV vaccine at baseline.
- •Receipt of any future licensed RSV vaccines during the study follow-up period will result in censorship on the date the vaccine was received.
- •All inclusion and exclusion criteria from P301 that are available in the RWD will be applied to the RWD controls, if built.
- •P301 key exclusion criteria:
- •Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
- •Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
- •History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
- •Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
- •Other inclusion and/or exclusion criteria may apply.
研究组 & 干预措施
mRNA-1345: Exposed
Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
干预措施: mRNA-1345 (Biological)
Placebo/Control: Referent
Eligible US participants from the P301 study who received placebo.
干预措施: Placebo (Biological)
结局指标
主要结局
Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV
时间窗: From Day 15 up to 1 year
次要结局
- Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV(From Day 15 up to 1 year)
- Mean Total Cost of Hospitalizations and Mean Total Healthcare Cost Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV(From Day 15 up to 1 year)
- Number of Participants with Use of Mechanical Ventilation, Supplemental Oxygen, and Intensive Care Unit Admissions During Hospitalizations Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV(From Day 15 up to 1 year)
- Number of Participants with Antibiotic or Corticosteroid Treatment(From Day 15 up to 1 year)
- Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma(From Day 15 up to 1 year)
- Number of Participants with First Incidence of Asthma, COPD, and CHF Exacerbations(From Day 15 up to 1 year)
研究者
研究点 (106)
Loading locations...
相似试验
已完成
不适用
A Study of the Effectiveness of Moderna COVID-19 VaccineSARS-CoV-2COVID-19NCT05933304ModernaTX, Inc.927,004
已完成
3 期
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of AgeRespiratory Syncytial VirusNCT06060457ModernaTX, Inc.1,900
进行中（未招募）
不适用
A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular DiseaseNCT06295679Amgen7,000
已完成
不适用
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault ProlapseUrinary Incontinence, StressMixed IncontinenceVaginal Vault ProlapseNCT00223106Medtronic - MITG467
进行中（未招募）
3 期
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute GastroenteritisNorovirus Acute GastroenteritisAcute GastroenteritisNCT06592794ModernaTX, Inc.37,864