Bellflower, CA

Coast Clinical Research LLC

Lyme Disease

Pfizer

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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.

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

Coast Clinical Research LLC | Bellflower, CA

Site insights

Work at this site?

Active trials

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

Trial sponsors