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
第3相
完了
NCT06060457
| 対象疾患 | Respiratory Syncytial Virus |
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| 相 | 第3相 |
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| スポンサー | ModernaTX, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 1,900 名 |
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| 介入（薬剤） | mRNA-1345, Fluzone HD |
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| 開始日 | 2023年9月25日 |
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| 完了日 | 2024年6月7日 |
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| 結果公開日 | 2025年7月30日 |
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概要
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 |
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| Fluzone HD + Placebo Followed by mRNA-1345 | 547 Participants |
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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 |
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| Fluzone HD + Placebo Followed by mRNA-1345 | 557 Participants |
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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 |
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| Fluzone HD + Placebo Followed by mRNA-1345 | 72 Participants |
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