Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Peadiatric And Adult Study Population

Inclusion Criteria:

• Subject is aged 5 to 65 years at the day of screening (Visit 0)
• Subject is of good general health

• Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions

  • for subjects aged 18-65 years: written informed consent prior to any study related procedures
  • for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.

• If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:

  • Main Study Phase: duration of entire study
  • Booster Phase: until Month 23 (i.e. 5 months after booster dose)
• Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
• Subject is available for the duration of the study and can be contacted by telephone during study participation

Exclusion Criteria:

• Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
• Subject received previous vaccination against LB;
• Subject had a tick bite within 4 weeks prior to Day 1;
• Subject has a medical history of or currently has a clinically relevant disease;
• Subject has a medical history of or currently has a neuro-inflammatory or autoimmune disease;
• Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
• Subject has received an active or passive immunization within 4 weeks prior to Day 1;
• Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
• Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
• Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
• Subject had any malignancy in the past 5 years;
• Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
• Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
• Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
• Subject is in a dependent relationship;