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NCT01827371 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 435
- Enrollment target
NCT01827371: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01827371 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 435 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (227% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827371, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 435 participants
- Enrollment target
Study Summary
Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study will look at condensed schedules. Study will randomize subjects to one of four arms.
Primary Outcome
Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.
Interventions
- BIOLOGICAL MVA Smallpox Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01827371 record still lists
NCT01827371 is an interventional study that assigns participants to a tested intervention. The registered 435 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (227% higher).
The record links to 0 conditions, and to 1 intervention - of which MVA Smallpox Vaccine is the first listed.
NCT01827371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01827371 about?
NCT01827371 is a clinical study titled "Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®". Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study will look at condensed schedul...
What is the current status of trial NCT01827371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 435 participants. The study started on 2013-06. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01827371?
The interventions under investigation include: MVA Smallpox Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01827371?
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 NCT01827371's enrollment target sits among peer trials
435 90th of 2000 higher than 1,911 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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