VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.
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Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Timeframe: From Day 1 to Day 7 after vaccination 1 at Month 0
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Timeframe: From Day 1 to Day 7 after vaccination 2 at Month 2
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Timeframe: From Day 1 to Day 7 after vaccination 3 at Month 6
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Timeframe: From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
Timeframe: Day 208 (Month 7)