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 Age
3期
已完成
NCT06060457
| 适应症 | Respiratory Syncytial Virus |
|---|
| 分期 | 3期 |
|---|
| 申办方 | ModernaTX, Inc. |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 1,900 人 |
|---|
| 干预（药物） | mRNA-1345, Fluzone HD |
|---|
| 开始日期 | 2023年9月25日 |
|---|
| 完成日期 | 2024年6月7日 |
|---|
| 结果公布日 | 2025年7月30日 |
|---|
摘要
The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Within 7 days after Day 1 injection · Participants
| Fluzone HD + mRNA-1345 Followed by Placebo | 689 Participants |
|---|
| Fluzone HD + Placebo Followed by mRNA-1345 | 547 Participants |
|---|
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection
Within 7 days after Day 22 injection · Participants
| Fluzone HD + mRNA-1345 Followed by Placebo | 251 Participants |
|---|
| Fluzone HD + Placebo Followed by mRNA-1345 | 557 Participants |
|---|
Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection
Up to 21 days after Day 1 injection · Participants
| Fluzone HD + mRNA-1345 Followed by Placebo | 72 Participants |
|---|
| Fluzone HD + Placebo Followed by mRNA-1345 | 72 Participants |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。