NCT05634811

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,549 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Lyme Disease

Interventions

Type	Name	Description
BIOLOGICAL	VLA15	6-valent OspA-based Lyme disease vaccine
OTHER	Normal Saline	0.9% sodium chloride solution for injection

Timeline

• Start date: 2022-12-12
• Primary completion: 2025-07-21
• Completion: 2025-07-21
• First posted: 2022-12-02
• Last updated: 2025-09-15

Locations

65 sites across 1 country: United States

Regulatory

• FDA-regulated drug study