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NCT03970733 · ClinicalTrials.gov registry record · Phase 2
Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 246
- Enrollment target
NCT03970733 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 246 participants.
The verdict
NCT03970733, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 246 participants
- Enrollment target
Study Summary
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180. In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18. Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months. Study duration per subject in the Booster Phase is a maximum of approximately 13 months. Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months. Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VLA15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2022-03-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03970733
The ClinicalTrials.gov registry entry for NCT03970733 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03970733 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03970733 about?
NCT03970733 is a clinical study titled "Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis". In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180. In the Booster Phase subje...
What is the current status of trial NCT03970733?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 246 participants. The study started on 2019-07-01. Estimated completion is 2022-03-28.
What interventions are being tested in trial NCT03970733?
The interventions under investigation include: Placebo (BIOLOGICAL), VLA15 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03970733?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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