Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
Summary
The purpose of this study was to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.
Timeline
- Start
- 2019-06-20
- Primary completion
- 2024-01-22
- Completion
- 2024-04-25
Outcome
Mixed primary results
Stopped (Enrollment): “The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.”
registry analysis (superiority test); RSV ΔNS2/Δ1313/I1314L Vaccine vs Placebo; p >0.99; Difference in proportions 0 (95% CI -32 to 32); Fisher Exact NCT03916185 ↗
registry analysis (superiority test); RSV ΔNS2/Δ1313/I1314L Vaccine vs Placebo; p <0.001; Difference in proportions 61 (95% CI 27 to 83); Fisher Exact NCT03916185 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RSV 276 | Vaccine | 100000 unknown | Intranasal |
| Subject | RSV 6120/ΔNS2/1030s | Vaccine | 100000 unknown | Intranasal |
| Subject | RSV ΔNS2/Δ1313/I1314L | Vaccine | 1e+06 unknown | Intranasal |