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NCT01968083 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in 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
- 51
- Enrollment target
NCT01968083: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01968083 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968083, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.
Primary Outcome
Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28)
Interventions
- BIOLOGICAL Placebo Vaccine
- BIOLOGICAL RSV cps2 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-10-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01968083 record still lists
NCT01968083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Vaccine is the first listed.
NCT01968083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01968083 about?
NCT01968083 is a clinical study titled "Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children". Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.
What is the current status of trial NCT01968083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2013-10-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01968083?
The interventions under investigation include: Placebo Vaccine (BIOLOGICAL), RSV cps2 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01968083?
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 NCT01968083's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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