Lyme Disease Vaccine for Healthy Children

Recruiting in Palo Alto (17 mi)

+74 other locations

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: * are healthy * are age 5 through 17 * have not been diagnosed with any form of Lyme disease in the past * have not received any vaccines for Lyme disease in the past Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group. Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo. Everyone participating in this study will: * get the shots in a clinic or in a hospital office * receive a total of 4 shots * receive the first 3 shots within 6 months * receive the last shot about 1 year afterwards * need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

Eligibility Criteria

Healthy children aged 5-17 who have never had Lyme disease or received a Lyme vaccine can join this study. They must be able to follow the study schedule and their parents/guardians agree to it. Kids with stable chronic conditions may participate, but those recently treated for Lyme, with known tick bites, on certain medications, or girls who are pregnant cannot.

Participant Groups

The trial is testing VLA15, a new vaccine aimed at preventing Lyme disease in kids. Participants will get either VLA15 or a placebo (normal saline) shot without knowing which one they receive. The study involves four shots over about two years and six clinic visits plus phone check-ins.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VLA15Experimental Treatment1 Intervention

Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).

Group II: Normal Saline (Placebo)Placebo Group1 Intervention

Participants will receive 0.9% sodium chloride solution for injection