Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
5–17
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy participants at enrollment who are determined to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
Participants and/or participants' parent(s)/guardian who are willing and able to comply with all scheduled visits, study procedures and lifestyle considerations for the duration of the study.
You may not be if
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.
