Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04801420
Eligibility Criteria:
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 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)
* 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 with the sponsor/investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
65 Years
Study:
NCT04801420
Study Brief:
Protocol Section:
NCT04801420