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NCT01668537 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
A Phase 2 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 2
- Development phase
- 651
- Enrollment target
NCT01668537: Completed Phase 2 study, sponsored by Bavarian Nordic.
NCT01668537 is a Phase 2 study that has completed, run by Bavarian Nordic. The registered enrollment target is 651 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (389% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01668537, a Phase 2 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 651 participants
- Enrollment target
Study Summary
A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects
Primary Outcome
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'
Interventions
- BIOLOGICAL LF formulation of IMVAMUNE®
- BIOLOGICAL FD formulation of IMVAMUNE®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 651 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT01668537 record still lists
NCT01668537 is an interventional study that assigns participants to a tested intervention. The registered 651 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 (389% higher).
The record links to 0 conditions, and to 2 interventions - of which LF formulation of IMVAMUNE® is the first listed.
NCT01668537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01668537 about?
NCT01668537 is a clinical study titled "A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects". A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects
What is the current status of trial NCT01668537?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 651 participants. The study started on 2013-03. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01668537?
The interventions under investigation include: LF formulation of IMVAMUNE® (BIOLOGICAL), FD formulation of IMVAMUNE® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01668537?
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 NCT01668537's enrollment target sits among peer trials
651 50th of 2000 higher than 1,951 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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