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NCT01144637 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
A Phase 3 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,005
- Enrollment target
NCT01144637: Completed Phase 3 study, sponsored by Bavarian Nordic.
NCT01144637 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 4,005 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (419% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01144637, a Phase 3 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,005 participants
- Enrollment target
Study Summary
A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.
Primary Outcome
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Interventions
- OTHER Placebo
- BIOLOGICAL IMVAMUNE®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,005 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01144637 record still lists
NCT01144637 is an interventional study that assigns participants to a tested intervention. Its 4,005 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (419% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01144637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01144637 about?
NCT01144637 is a clinical study titled "A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects". A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.
What is the current status of trial NCT01144637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,005 participants. The study started on 2013-02. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01144637?
The interventions under investigation include: Placebo (OTHER), IMVAMUNE® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01144637?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01144637's enrollment target sits among peer trials
4,005 61st of 2000 higher than 1,940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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