Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis

About the trial

Sponsor

Pfizer (with Valneva Austria GmbH)

Tested

VLA15 (biological), Placebo (biological)

Dates

Started 2019-07-01; completion 2022-03-28

Results posted

Yes

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 o…

From ClinicalTrials.gov, last updated 2023-04-21. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Valneva Austria GmbH reported $41,879 in research payments for this study in 2025 (3 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.