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

A legfontosabb adatok

Hol
Austin, Bardstown, Bellflower, Bingham Farms, Binghamton, Birmingham, Boise, Bridgeport, Buffalo, Chamblee, Charlottesville, Chicago, Columbus, Commack, Cortland, Dearborn Heights, East Setauket, East Syracuse, El Dorado, Erie, Fair Oaks, Fort Worth, Guntersville, Hampton Bays, Horseheads, Houston, Idaho Falls, Kingwood, Louisville, Marlton, Miami, Mineola, Minneapolis, New Brunswick, North Charleston, North Massapequa, Omaha, Oxon Hill, Pittsburgh, Plano, Rexburg, Richmond, Rochester, San Antonio, Scranton, Silver Spring, Southfield, Springfield, St. Petersburg, Stamford, Stony Brook, Tampa, The Bronx, Vestal, Warren Township, Washington D.C., West Jordan és Wichita (Egyesült Államok)Mind a 65 helyszín megnézése
Fázis
3. fázis

Helyszínek itt: Egyesült Államok

  • Benchmark ResearchAustin, Egyesült ÁllamokNo longer taking part
  • Kentucky Pediatric/ Adult ResearchBardstown, Egyesült ÁllamokNo longer taking part
  • Coast Clinical Research, LLCBellflower, Egyesült ÁllamokNo longer taking part
  • Michigan Center of Medical Research (MICHMER)Bingham Farms, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - BinghamtonBinghamton, Egyesült ÁllamokNo longer taking part
  • UAB Child Health Research Unit (CHRU)Birmingham, Egyesült ÁllamokNo longer taking part
  • University of Alabama at Birmingham School of MedicineBirmingham, Egyesült ÁllamokNo longer taking part
  • ASR, LLCBoise, Egyesült ÁllamokNo longer taking part
  • New England Research AssociatesBridgeport, Egyesült ÁllamokNo longer taking part
  • Buffalo Clinical and Translational Research CenterBuffalo, Egyesült ÁllamokNo longer taking part
  • Tekton Research, LLC.Chamblee, Egyesült ÁllamokNo longer taking part
  • Pediatric Research of Charlottesville, LLCCharlottesville, Egyesült ÁllamokNo longer taking part
  • University of Chicago Medical CenterChicago, Egyesült ÁllamokNo longer taking part
  • Centricity Research Columbus Ohio MultispecialtyColumbus, Egyesült ÁllamokNo longer taking part
  • Advanced Specialty CareCommack, Egyesült ÁllamokNo longer taking part
  • Smith Allergy and Asthma SpecialistsCortland, Egyesült ÁllamokNo longer taking part
  • Vida Clinical Studies, LLCDearborn Heights, Egyesült ÁllamokNo longer taking part
  • Stony Brook Medicine Clinical Research CenterEast Setauket, Egyesült ÁllamokNo longer taking part
  • Upstate Global Health InstituteEast Syracuse, Egyesült ÁllamokNo longer taking part
  • AMR ClinicalEl Dorado, Egyesült ÁllamokNo longer taking part
  • Allegheny Health and Wellness PavilionErie, Egyesült ÁllamokNo longer taking part
  • Central Erie Primary CareErie, Egyesült ÁllamokNo longer taking part
  • Apex Research Group LLCFair Oaks, Egyesült ÁllamokNo longer taking part
  • Benchmark ResearchFort Worth, Egyesült ÁllamokNo longer taking part
  • Texas Health ResourcesFort Worth, Egyesült ÁllamokNo longer taking part
  • Lakeview Clinical ResearchGuntersville, Egyesült ÁllamokNo longer taking part
  • Southampton HospitalHampton Bays, Egyesült ÁllamokNo longer taking part
  • Smith Allergy & Asthma SpecialistsHorseheads, Egyesült ÁllamokNo longer taking part
  • C & R Research Services USAHouston, Egyesült ÁllamokNo longer taking part
  • DM Clinical Research - Kool Kids PediatricsHouston, Egyesült ÁllamokNo longer taking part
  • Clinical Research PrimeIdaho Falls, Egyesült ÁllamokNo longer taking part
  • Frontier Clinical ResearchKingwood, Egyesült ÁllamokNo longer taking part
  • Preston Healthcare ServicesKingwood, Egyesült ÁllamokNo longer taking part
  • All Children PediatricsLouisville, Egyesült ÁllamokNo longer taking part
  • Hassman Research InstituteMarlton, Egyesült ÁllamokNo longer taking part
  • Bio-Medical Research LLCMiami, Egyesült ÁllamokNo longer taking part
  • NYU Langone Hospital - Long IslandMineola, Egyesült ÁllamokNo longer taking part
  • Clinical Research InstituteMinneapolis, Egyesült ÁllamokNo longer taking part
  • Rutgers UniversityNew Brunswick, Egyesült ÁllamokNo longer taking part
  • Coastal Carolina Research CenterNorth Charleston, Egyesült ÁllamokNo longer taking part
  • DiGiovanna Institute for Medical Education & ResearchNorth Massapequa, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - OmahaOmaha, Egyesült ÁllamokNo longer taking part
  • MD Medical ResearchOxon Hill, Egyesült ÁllamokNo longer taking part
  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Pittsburgh, Egyesült ÁllamokNo longer taking part
  • Research Your HealthPlano, Egyesült ÁllamokNo longer taking part
  • Clinical Research Prime RexburgRexburg, Egyesült ÁllamokNo longer taking part
  • Clinical Research Partners, LLCRichmond, Egyesült ÁllamokNo longer taking part
  • Rochester Clinical Research, LLCRochester, Egyesült ÁllamokNo longer taking part
  • Sun Research InstituteSan Antonio, Egyesült ÁllamokNo longer taking part
  • Northeast Clinical Trials GroupScranton, Egyesült ÁllamokNo longer taking part
  • White Oak PediatricsSilver Spring, Egyesült ÁllamokNo longer taking part
  • Great Lakes Research InstituteSouthfield, Egyesült ÁllamokNo longer taking part
  • Sisu BHRSpringfield, Egyesült ÁllamokNo longer taking part
  • GCP Research, Global Clinical professionalsSt. Petersburg, Egyesült ÁllamokNo longer taking part
  • Stamford Therapeutics ConsortiumStamford, Egyesült ÁllamokNo longer taking part
  • Stony Brook UniversityStony Brook, Egyesült ÁllamokNo longer taking part
  • ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
  • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
  • Advantage Clinical TrialsThe Bronx, Egyesült ÁllamokNo longer taking part
  • Prime Global ResearchThe Bronx, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - VestalVestal, Egyesült ÁllamokNo longer taking part
  • IMA Clinical Research WarrenWarren Township, Egyesült ÁllamokNo longer taking part
  • Children's National Medical CenterWashington D.C., Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research, Salt Lake CityWest Jordan, Egyesült ÁllamokNo longer taking part
  • AMR ClinicalWichita, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
Pfizer
Azonosító
NCT05634811
A regiszteradat frissítve
2026. május 7.
Eredeti leírás
This study is to understand if the study vaccine (called VLA15) is safe in healthy children.A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: 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.

Kizáró feltételek: Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components; 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); 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; 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; 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; Known tick bite within the past 4 weeks; 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.

ClinicalTrials.gov NCT05634811