A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE
A research study on an experimental vaccine for Lyme disease. The study doctor wants to learn how safe the vaccine is for children between 5 and 17 years old. This vaccine could make the body to produce a defense against the bacteria that causes Lyme disease. This illness can happen when a tick carrying the bacteria bites a person and passes the bacteria to that person.
If your child participates in the study, he or she will be assigned by chance (like flipping a coin) to receive either VLA15 vaccine or a placebo through the whole study. Placebo is an inactive substance consisting of saline (saltwater). Your child’s chance to receive VLA15 or placebo will be about 3:1. This means that for every four people in the study, 3 of them are likely to get VLA15. He or she will receive a total of 4 doses over the whole study. The first 3 doses are given beginning when you join the study (“Month 0”) and then 2 and 6 months later. The last dose is given about a year after the third dose, or about 18 months after beginning the study. The study vaccine will be given as an injection (a “shot”) administered in the muscle of the top part of your arm. People taking part will be in this study for about 2 years. If your child is enrolled, he or she will need to visit the research site at least 6 times during the study. There will also be at least 2 telephone contacts. Additionally, your child may need to visit the site if he or she has severe reactions after vaccinations. There are no blood draws.
Healthy children who are determined by medical history and medical judgment of the physician
Willing and able to comply with all scheduled visits, lifestyle considerations, and other study procedures; are expected to be available for the duration of the study; and can be contacted by telephone during study participation
Any contraindication to vaccination or vaccine components, including previous severe allergic reaction to any vaccine or vaccine-related components.
Any diagnosis of Lyme Disease within the past 3 months or known tick bite within the past 4 weeks
Any history of long term Lyme Disease conditions regardless of when diagnosed.
Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for female participants at Visit 1