A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Phase 3
Terminated
NCT06705140
| Condition | RSV Immunisation, Healthy Volunteers |
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| Phase | Phase 3 |
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| Sponsor | Sanofi Pasteur, a Sanofi Company |
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| Status | Terminated |
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| Enrollment | 42 participants |
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| Interventions | Low Dose (LD) RSVt vaccine, Standard Dose (SD) RSVt vaccine, High Dose (HD) RSVt vaccine |
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| Start date | Nov 25, 2024 |
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| Completion date | Jun 11, 2025 |
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| Results posted | Aug 3, 2026 |
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Summary
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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Open in BENITIONS
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