Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

Exclusion Criteria

• •Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol.
• •Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
• •Any diagnosis of Lyme disease within the past 3 months.
• •Any history of Lyme arthritis, carditis, neuroborreliosis, or other disseminated Lyme Disease (LD), regardless of when diagnosed.
• •Known tick bite within the past 4 weeks.
• •Congenital or acquired immunodeficiency or other conditions or treatments associated with immunosuppression that would inhibit the ability to mount an immune response to a vaccine.
• •Other medical, psychiatric condition, active suicidal ideation/behavior or lab abnormality which increases risk of study participation or, in investigator's judgment is inappropriate for the study.
• •Receipt of a previous vaccination for LD.
• •Treatment for LD in the 3 months prior to study intervention administration.
• •Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
• •Receipt of systemic corticosteroids for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical corticosteroids are permitted.
• •Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
• •Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
• •Participation in other studies involving investigational drugs/vaccines/devices within 28 days prior to study entry and/or during study participation (observational studies are acceptable).
• •Investigator site staff, sponsor/sponsor delegates directly involved in the conduct of the study and their family members; site staff supervised by the investigator and their family members.