A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
3期
提前终止
NCT06705140
| 适应症 | RSV Immunisation, Healthy Volunteers |
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| 分期 | 3期 |
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| 申办方 | Sanofi Pasteur, a Sanofi Company |
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| 状态 | 提前终止 |
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| 受试者人数 | 42 人 |
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| 干预（药物） | Low Dose (LD) RSVt vaccine, Standard Dose (SD) RSVt vaccine, High Dose (HD) RSVt vaccine |
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| 开始日期 | 2024年11月25日 |
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| 完成日期 | 2025年6月11日 |
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| 结果公布日 | 2026年8月3日 |
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摘要
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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