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NCT03699124 · ClinicalTrials.gov registry record · Phase 3
Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial
A Phase 3 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,129
- Enrollment target
NCT03699124: Completed Phase 3 study, sponsored by Bavarian Nordic.
NCT03699124 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 1,129 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03699124, a Phase 3 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,129 participants
- Enrollment target
Study Summary
This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be given to healthy subjects who do not have a smallpox scar. Approximately 1110 subjects will be randomly enrolled into one of three groups: Group 1 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 1). Group 2 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 2). Group 3 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 3). The primary objective of the trial is to show that the immune response elicited (produced) by three consecutively produced MVA-BN lots are statistically (numerically) comparable.
Primary Outcome
Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20.
Interventions
- BIOLOGICAL FD MVA-BN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,129 participants |
| Start Date | 2019-06-19 |
| Est. Completion | 2020-06-22 |
| Phase | Phase 3 |
What the finished NCT03699124 record still lists
NCT03699124 is an interventional study that assigns participants to a tested intervention. Its 1,129 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 (46% higher).
The record links to 0 conditions, and to 1 intervention - of which FD MVA-BN is the first listed.
NCT03699124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03699124 about?
NCT03699124 is a clinical study titled "Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial". This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be given to healthy subjects who do not have a smallpox scar. Approximately 1110 subjects will be randomly enrolled into one...
What is the current status of trial NCT03699124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,129 participants. The study started on 2019-06-19. Estimated completion is 2020-06-22.
What interventions are being tested in trial NCT03699124?
The interventions under investigation include: FD MVA-BN (BIOLOGICAL).
Who is sponsoring clinical trial NCT03699124?
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 NCT03699124's enrollment target sits among peer trials
1,129 247th of 2000 higher than 1,754 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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