An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →. With Valneva Austria GmbH.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
12,546actual
Sites
129
Countries
Canada, Finland, Germany +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-04 | actual | When the study began enrolling |
| Primary completion | 2026-01-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-07 | actual | The whole study's end, after follow-up |
| First posted | 2022-07-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lyme Disease
Interventions
- Biological: VLA15
- Other: Saline
Primary outcomes
what the primary-completion date above is the date OFRelative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group
measured Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)).
Percentage of participants reporting local reactions
measured Within 7 days following each study intervention administration
Percentage of participants reporting systemic events
measured Within 7 days following each study intervention administration
Percentage of participants reporting adverse events (AEs)
measured Through 1 month following each study intervention administration
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
measured Through study completion, up to approximately 42 months.
Percentage of participants reporting serious adverse events (SAEs)
measured Through study completion, up to approximately 42 months.
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2
measured At 1 month after completion of the primary series and the booster dose
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3
measured At 1 month after completion of the primary series and the booster dose
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3
measured At 1 month after completion of the primary series and the booster dose
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)
measured At 1 month after completion of the booster dose
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6)
measured At 1 month after completion of the booster dose
Publications
- PMID 38262807 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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