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
第1相
完了
NCT04520659
| 対象疾患 | RSV Infection |
|---|
| 相 | 第1相 |
|---|
| スポンサー | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 81 名 |
|---|
| 介入（薬剤） | RSV LID/ΔM2-2/1030s |
|---|
| 開始日 | 2022年3月16日 |
|---|
| 完了日 | 2024年4月18日 |
|---|
| 結果公開日 | 2025年8月22日 |
|---|
概要
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 |
|---|
| Group 1: Placebo | 7 Participants |
|---|
| Group 2: RSV LID/ΔM2-2/1030s | 27 Participants |
|---|
| Group 2: Placebo | 11 Participants |
|---|
| Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | 41 Participants |
|---|
| Groups 1 and 2 Combined: Placebo | 18 Participants |
|---|
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 |
|---|
| Group 1: Placebo | 7 Participants |
|---|
| Group 2: RSV LID/ΔM2-2/1030s | 39 Participants |
|---|
| Group 2: Placebo | 17 Participants |
|---|
| Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | 53 Participants |
|---|
| Groups 1 and 2 Combined: Placebo | 24 Participants |
|---|
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 |
|---|
| Group 1: Placebo | 6 Participants |
|---|
| Group 2: RSV LID/ΔM2-2/1030s | 29 Participants |
|---|
| Group 2: Placebo | 16 Participants |
|---|
| Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | 43 Participants |
|---|
| Groups 1 and 2 Combined: Placebo | 22 Participants |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。