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Lyme vaccine passes safety check in 3,500 kids

NCT ID NCT05634811

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new Lyme disease vaccine (VLA15) is safe for healthy children ages 5 to 17. Over 3,500 kids received either the vaccine or a placebo (saltwater shot) and were monitored for about 2 years. The main goal was to check for side effects like pain, redness, fever, or other reactions after each of the 4 shots. The study has been completed, and the results will help decide if the vaccine can be used to prevent Lyme disease in children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,547 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy participants at enrollment who are determined to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included. * 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: * Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol. * 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.

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Conditions

The condition(s) this trial relates to.

Borrelia infectious disease vector-borne disease Lyme disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lyme disease

Contacts and locations

Locations

  • AMR Clinical

    El Dorado, Kansas, 67042, United States

  • AMR Clinical

    Wichita, Kansas, 67207, United States

  • ASR, LLC

    Boise, Idaho, 83702, United States

  • Advanced Specialty Care

    Commack, New York, 11725, United States

  • Advantage Clinical Trials

    The Bronx, New York, 10467, United States

  • All Children Pediatrics

    Louisville, Kentucky, 40243, United States

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506, United States

  • Apex Research Group LLC

    Fair Oaks, California, 95628, United States

  • Benchmark Research

    Austin, Texas, 78705, United States

  • Benchmark Research

    Fort Worth, Texas, 76135, United States

  • Bio-Medical Research LLC

    Miami, Florida, 33144, United States

  • Buffalo Clinical and Translational Research Center

    Buffalo, New York, 14203, United States

  • C & R Research Services USA

    Houston, Texas, 77022, United States

  • Central Erie Primary Care

    Erie, Pennsylvania, 16508, United States

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402, United States

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Clinical Research Prime Rexburg

    Rexburg, Idaho, 83440, United States

  • Coast Clinical Research, LLC

    Bellflower, California, 90706, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • DM Clinical Research - Kool Kids Pediatrics

    Houston, Texas, 77065, United States

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York, 11758, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • Frontier Clinical research

    Kingwood, West Virginia, 26537, United States

  • GCP Research, Global Clinical professionals

    St. Petersburg, Florida, 33705, United States

  • Great Lakes Research Institute

    Southfield, Michigan, 48075, United States

  • Hassman Research Institute

    Marlton, New Jersey, 08053, United States

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059, United States

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976, United States

  • MD Medical Research

    Oxon Hill, Maryland, 20745, United States

  • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

    Tampa, Florida, 33609, United States

  • Michigan Center of Medical Research (MICHMER)

    Bingham Farms, Michigan, 48025, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • New England Research Associates

    Bridgeport, Connecticut, 06606, United States

  • Northeast Clinical Trials Group

    Scranton, Pennsylvania, 18510, United States

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902, United States

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania, 15236, United States

  • Preston Healthcare Services

    Kingwood, West Virginia, 26537, United States

  • Prime Global Research

    The Bronx, New York, 10456, United States

  • Research Your Health

    Plano, Texas, 75093, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

  • Rutgers University

    New Brunswick, New Jersey, 08901, United States

  • Sisu BHR

    Springfield, Massachusetts, 01103, United States

  • Smith Allergy & Asthma Specialists

    Horseheads, New York, 14845, United States

  • Smith Allergy and Asthma Specialists

    Cortland, New York, 13045, United States

  • Southampton Hospital

    Hampton Bays, New York, 11946, United States

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905, United States

  • Stony Brook Medicine Clinical Research Center

    East Setauket, New York, 11733, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Tekton Research, LLC.

    Chamblee, Georgia, 30341, United States

  • Texas Health Resources

    Fort Worth, Texas, 76135, United States

  • UAB Child Health Research Unit (CHRU)

    Birmingham, Alabama, 35233, United States

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama, 35233, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • Upstate Global Health Institute

    East Syracuse, New York, 13057, United States

  • Velocity Clinical Research, Binghamton

    Binghamton, New York, 13905, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Vestal

    Vestal, New York, 13850, United States

  • Vida Clinical Studies, LLC

    Dearborn Heights, Michigan, 48127, United States

  • White Oak Pediatrics

    Silver Spring, Maryland, 20904, United States

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