Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age
1期
已完成
NCT04520659
| 适应症 | RSV Infection |
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| 分期 | 1期 |
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| 申办方 | National Institute of Allergy and Infectious Diseases (NIAID) |
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| 状态 | 已完成 |
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| 受试者人数 | 81 人 |
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| 干预（药物） | RSV LID/ΔM2-2/1030s |
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| 开始日期 | 2022年3月16日 |
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| 完成日期 | 2024年4月18日 |
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| 结果公布日 | 2025年8月22日 |
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摘要
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Measured through Day 28 · Participants
| Group 1: RSV LID/ΔM2-2/1030s | 14 Participants |
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| Group 1: Placebo | 7 Participants |
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| Group 2: RSV LID/ΔM2-2/1030s | 27 Participants |
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| Group 2: Placebo | 11 Participants |
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| Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | 41 Participants |
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| Groups 1 and 2 Combined: Placebo | 18 Participants |
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Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Measured through Day 28 · Participants
| Group 1: RSV LID/ΔM2-2/1030s | 14 Participants |
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| Group 1: Placebo | 7 Participants |
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| Group 2: RSV LID/ΔM2-2/1030s | 39 Participants |
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| Group 2: Placebo | 17 Participants |
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| Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | 53 Participants |
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| Groups 1 and 2 Combined: Placebo | 24 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Measured through Day 28 · Participants
| Group 1: RSV LID/ΔM2-2/1030s | 14 Participants |
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| Group 1: Placebo | 6 Participants |
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| Group 2: RSV LID/ΔM2-2/1030s | 29 Participants |
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| Group 2: Placebo | 16 Participants |
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| Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | 43 Participants |
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| Groups 1 and 2 Combined: Placebo | 22 Participants |
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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。