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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 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 1,129 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03699124
The ClinicalTrials.gov registry entry for NCT03699124 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FD MVA-BN is the first listed.
NCT03699124 reports 0 study locations.
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.
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