A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
第3相
早期終了
NCT06705140
| 対象疾患 | RSV Immunisation, Healthy Volunteers |
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| 相 | 第3相 |
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| スポンサー | Sanofi Pasteur, a Sanofi Company |
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| ステータス | 早期終了 |
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| 参加者数 | 42 名 |
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| 介入（薬剤） | Low Dose (LD) RSVt vaccine, Standard Dose (SD) RSVt vaccine, High Dose (HD) RSVt vaccine |
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| 開始日 | 2024年11月25日 |
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| 完了日 | 2025年6月11日 |
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| 結果公開日 | 2026年8月3日 |
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概要
This study was a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study conducted in 42 healthy children enrolled at 6 months to \<22 months of age. The purpose of the study was to evaluate the non-inferiority of the immune response of the lower dose (LD) when compared to the standard dose (SD) respiratory syncytial virus infant and toddler (RSVt) vaccine and the safety of the LD, SD and high dose (HD) vaccine in preterm born children and of the HD vaccine in full term born children administered by intranasal route and compared to placebo.
Cohort 2: Geometric Mean Titers (GMT) of RSV A Serum Neutralizing Antibodies at Day 85 (Post-Dose 2)
Day 85 (28 days post-vaccination 2)
Cohort 2: Geometric Mean Titers of RSV B Serum Neutralizing Antibodies at Day 85 (Post-Dose 2)
Day 85 (28 days post-vaccination 2)
Cohorts 1 and 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Up to 30 minutes after each vaccination (post-dose on Day 1) · Participants
| Cohort 1: Group 1: Standard Dose RSVt | 0 Participants |
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| Cohort 1: Group 2: Placebo | 0 Participants |
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| Cohort 2: Group 1: Low Dose RSVt | 0 Participants |
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| Cohort 2: Group 2: Standard Dose RSVt | 0 Participants |
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| Cohort 2: Group 3: High Dose RSVt | 0 Participants |
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| Cohort 2: Group 4: Placebo | 0 Participants |
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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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