Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Lyme Borreliosis
In brief
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.
Key facts
- Study ID
- NCT03970733
- Run by
- Pfizer
- People needed
- 246
- Starts
- 2019-07-01
- Expected to finish
- 2022-03-28
- Last updated by the study team
- 2023-04-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- Clinical Research Consulting, LLC — Milford, Connecticut, United States
- Stamford Therapeutics Consortium — Stamford, Connecticut, United States
- United Medical Associates — Binghamton, New York, United States
- Regional Clinical Research, Inc — Endwell, New York, United States
- Rochester Clinical Research, Inc. — Rochester, New York, United States
Full record on ClinicalTrials.gov
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