Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
Public ClinicalTrials.gov record NCT05634811. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05634811
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,547 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2022 (Actual)
- Primary completion
- Jul 21, 2025 (Actual)
- Completion
- Jul 21, 2025 (Actual)
- Last update posted
- May 7, 2026
2022 – 2025
United States locations
- U.S. sites
- 65
- U.S. states
- 24
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Child Health Research Unit (CHRU) | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham - School of Medicine | Birmingham | Alabama | 35233 | — |
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | — |
| Coast Clinical Research, LLC | Bellflower | California | 90706 | — |
| Apex Research Group LLC | Fair Oaks | California | 95628 | — |
| New England Research Associates | Bridgeport | Connecticut | 06606 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Bio-Medical Research LLC | Miami | Florida | 33144 | — |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | 33705 | — |
| MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research | Tampa | Florida | 33609 | — |
| ForCare Clinical Research | Tampa | Florida | 33613 | — |
| Tekton Research, LLC. | Chamblee | Georgia | 30341 | — |
| ASR, LLC | Boise | Idaho | 83702 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Clinical Research Prime Rexburg | Rexburg | Idaho | 83440 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| AMR Clinical | El Dorado | Kansas | 67042 | — |
| AMR Clinical | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| All Children Pediatrics | Louisville | Kentucky | 40243 | — |
| MD Medical Research | Oxon Hill | Maryland | 20745 | — |
| White Oak Pediatrics | Silver Spring | Maryland | 20904 | — |
| Sisu BHR | Springfield | Massachusetts | 01103 | — |
| Michigan Center of Medical Research (MICHMER) | Bingham Farms | Michigan | 48025 | — |
| Vida Clinical Studies, LLC | Dearborn Heights | Michigan | 48127 | — |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | — |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | — |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | — |
| Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Rutgers University | New Brunswick | New Jersey | 08901 | — |
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | — |
| Velocity Clinical Research, Binghamton | Binghamton | New York | 13905 | — |
| Buffalo Clinical and Translational Research Center | Buffalo | New York | 14203 | — |
| Advanced Specialty Care | Commack | New York | 11725 | — |
| Smith Allergy and Asthma Specialists | Cortland | New York | 13045 | — |
| Stony Brook Medicine Clinical Research Center | East Setauket | New York | 11733 | — |
| Upstate Global Health Institute | East Syracuse | New York | 13057 | — |
| Southampton Hospital | Hampton Bays | New York | 11946 | — |
| Smith Allergy & Asthma Specialists | Horseheads | New York | 14845 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758 | — |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| Prime Global Research | The Bronx | New York | 10456 | — |
| Advantage Clinical Trials | The Bronx | New York | 10467 | — |
| Velocity Clinical Research, Vestal | Vestal | New York | 13850 | — |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | — |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | — |
| Central Erie Primary Care | Erie | Pennsylvania | 16508 | — |
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Pittsburgh | Pennsylvania | 15236 | — |
| Northeast Clinical Trials Group | Scranton | Pennsylvania | 18510 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Texas Health Resources | Fort Worth | Texas | 76135 | — |
| C & R Research Services USA | Houston | Texas | 77022 | — |
| DM Clinical Research - Kool Kids Pediatrics | Houston | Texas | 77065 | — |
| Research Your Health | Plano | Texas | 75093 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | — |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | — |
| Frontier Clinical research | Kingwood | West Virginia | 26537 | — |
| Preston Healthcare Services | Kingwood | West Virginia | 26537 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05634811, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2026 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05634811 live on ClinicalTrials.gov.