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NCT03387137 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03387137: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03387137 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387137, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV 6120/∆NS2/1030s) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.
Primary Outcome
Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix IV of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV 6120/∆NS2/1030s
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 1 |
What the finished NCT03387137 record still lists
NCT03387137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03387137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03387137 about?
NCT03387137 is a clinical study titled "Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children". The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV 6120/∆NS2/1030s) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 2...
What is the current status of trial NCT03387137?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2017-10-13. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT03387137?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV 6120/∆NS2/1030s (BIOLOGICAL).
Who is sponsoring clinical trial NCT03387137?
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 NCT03387137's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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