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NCT03916185 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT03916185: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03916185 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916185, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
Solicited adverse events include fever, otitis media, upper respiratory illness (URI), and lower respiratory illness (LRI) and are graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited AEs with at least mild severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV ΔNS2/Δ1313/I1314L Vaccine
- BIOLOGICAL RSV 6120/ΔNS2/1030s Vaccine
- BIOLOGICAL RSV 276 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2024-04-25 |
| Phase | Phase 1 |
Why NCT03916185 stopped before completion
NCT03916185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03916185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03916185 about?
NCT03916185 is a clinical study titled "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". 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.
What is the current status of trial NCT03916185?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2019-06-20. Estimated completion is 2024-04-25.
What interventions are being tested in trial NCT03916185?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV ΔNS2/Δ1313/I1314L Vaccine (BIOLOGICAL), RSV 6120/ΔNS2/1030s Vaccine (BIOLOGICAL), RSV 276 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03916185?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03916185's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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