Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
NCT ID: NCT05634811
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3549 participants
INTERVENTIONAL
2022-12-12
2025-07-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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VLA15
Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).
VLA15
6-valent OspA-based Lyme disease vaccine
Normal Saline (Placebo)
Participants will receive 0.9% sodium chloride solution for injection
Normal Saline
0.9% sodium chloride solution for injection
Interventions
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VLA15
6-valent OspA-based Lyme disease vaccine
Normal Saline
0.9% sodium chloride solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
5 Years
17 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UAB Child Health Research Unit (CHRU)
Birmingham, Alabama, United States
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
Coast Clinical Research, LLC
Bellflower, California, United States
Apex Research Group LLC
Fair Oaks, California, United States
New England Research Associates
Bridgeport, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Bio-Medical Research LLC
Miami, Florida, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Tekton Research, LLC.
Chamblee, Georgia, United States
ASR, LLC
Boise, Idaho, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg
Rexburg, Idaho, United States
University of Chicago Medical Center
Chicago, Illinois, United States
AMR Clinical
El Dorado, Kansas, United States
AMR Clinical
Wichita, Kansas, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
All Children Pediatrics
Louisville, Kentucky, United States
MD Medical Research
Oxon Hill, Maryland, United States
White Oak Pediatrics
Silver Spring, Maryland, United States
Sisu BHR
Springfield, Massachusetts, United States
Michigan Center of Medical Research (MICHMER)
Bingham Farms, Michigan, United States
Vida Clinical Studies, LLC
Dearborn Heights, Michigan, United States
Great Lakes Research Institute
Southfield, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Hassman Research Institute
Marlton, New Jersey, United States
Rutgers University
New Brunswick, New Jersey, United States
IMA Clinical Research Warren
Warren Township, New Jersey, United States
Velocity Clinical Research, Binghamton
Binghamton, New York, United States
Buffalo Clinical and Translational Research Center
Buffalo, New York, United States
Advanced Specialty Care
Commack, New York, United States
Smith Allergy and Asthma Specialists
Cortland, New York, United States
Stony Brook Medicine Clinical Research Center
East Setauket, New York, United States
Upstate Global Health Institute
East Syracuse, New York, United States
Southampton Hospital
Hampton Bays, New York, United States
Smith Allergy & Asthma Specialists
Horseheads, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
Prime Global Research
The Bronx, New York, United States
Advantage Clinical Trials
The Bronx, New York, United States
Velocity Clinical Research, Vestal
Vestal, New York, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Central Erie Primary Care
Erie, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, United States
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Benchmark Research
Austin, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Texas Health Resources
Fort Worth, Texas, United States
C & R Research Services USA
Houston, Texas, United States
DM Clinical Research - Kool Kids Pediatrics
Houston, Texas, United States
Research Your Health
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Frontier Clinical research
Kingwood, West Virginia, United States
Preston Healthcare Services
Kingwood, West Virginia, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05634811
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-000441-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4601012
Identifier Type: -
Identifier Source: org_study_id
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