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Sikkerhedsundersøgelse af en vaccine, der hjælper med at beskytte mod Lyme-sygdom hos raske børn

14. april 2026 opdateret af: Pfizer

ET FASE 3, RANDOMISERET, PLACEBO-KONTROLLERET, OBSERVATØR-BLINDET FORSØG TIL EVALUERING AF SIKKERHEDEN AF EN 6-VALENT OspA-BASERET LYMESYGDOMVACCINE (VLA15) HOS SUNDE BØRN I alderen 5 TIL 17 ÅR

Denne undersøgelse skal forstå, om undersøgelsesvaccinen (kaldet VLA15) er sikker hos raske børn.

Vi søger børn, der:

  • er sunde
  • er i alderen 5 til 17
  • har ikke tidligere været diagnosticeret med nogen form for borreliose
  • ikke har modtaget nogen vacciner mod borreliose tidligere

Lyme-sygdom forekommer oftest hos børn i denne alder. Studievaccinen kan potentielt bruges til at forhindre borreliose. Målet med denne undersøgelse er at få mere information om sikkerheden af ​​undersøgelsesvaccinen i denne aldersgruppe.

Deltagerne vil være i denne undersøgelse i omkring 2 år. I løbet af den tid vil de modtage VLA15 eller placebo (steril saltvandsopløsning) ved et "skud" i armen. Vi vil sammenligne erfaringer med børn, der fik VLA15, med dem, der fik placebo. Deltagerne vil ikke vide, om de får VLA15 eller placebo.

Alle, der deltager i denne undersøgelse, vil:

  • få skud på en klinik eller på et hospitalskontor
  • modtage i alt 4 skud
  • modtage de første 3 skud inden for 6 måneder
  • modtage det sidste skud cirka 1 år efter
  • behov for at komme til forsøgsstedet for 6 planlagte besøg; 4 af disse er vaccinationsbesøg og 2 er opfølgningsbesøg. Vi kontakter dig telefonisk 1 gang om året i løbet af undersøgelsen for at følge din oplevelse. Du kan få ekstra besøg, hvis du oplever en alvorlig reaktion efter en vaccinedosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3547

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham - School of Medicine
      • Birmingham, Alabama, Forenede Stater, 35233
        • UAB Child Health Research Unit (CHRU)
      • Guntersville, Alabama, Forenede Stater, 35976
        • Lakeview Clinical Research
    • California
      • Bellflower, California, Forenede Stater, 90706
        • Coast Clinical Research, LLC
      • Fair Oaks, California, Forenede Stater, 95628
        • Apex Research Group LLC
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
        • New England Research Associates
      • Stamford, Connecticut, Forenede Stater, 06905
        • Stamford Therapeutics Consortium
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Children's National Medical Center
    • Florida
      • Miami, Florida, Forenede Stater, 33144
        • Bio-Medical Research LLC
      • St. Petersburg, Florida, Forenede Stater, 33705
        • GCP Research, Global Clinical professionals
      • Tampa, Florida, Forenede Stater, 33613
        • ForCare Clinical Research
      • Tampa, Florida, Forenede Stater, 33609
        • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
    • Georgia
      • Chamblee, Georgia, Forenede Stater, 30341
        • Tekton Research, LLC.
    • Idaho
      • Boise, Idaho, Forenede Stater, 83702
        • ASR, LLC
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Clinical Research Prime
      • Rexburg, Idaho, Forenede Stater, 83440
        • Clinical Research Prime Rexburg
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Medical Center
    • Kansas
      • El Dorado, Kansas, Forenede Stater, 67042
        • AMR Clinical
      • Wichita, Kansas, Forenede Stater, 67207
        • AMR Clinical
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004
        • Kentucky Pediatric/ Adult Research
      • Louisville, Kentucky, Forenede Stater, 40243
        • All Children Pediatrics
    • Maryland
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • MD Medical Research
      • Silver Spring, Maryland, Forenede Stater, 20904
        • White Oak Pediatrics
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01103
        • Sisu BHR
    • Michigan
      • Bingham Farms, Michigan, Forenede Stater, 48025
        • Michigan Center of Medical Research (MICHMER)
      • Dearborn Heights, Michigan, Forenede Stater, 48127
        • Vida Clinical Studies, LLC
      • Southfield, Michigan, Forenede Stater, 48075
        • Great Lakes Research Institute
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55402
        • Clinical Research Institute
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68134
        • Velocity Clinical Research, Omaha
    • New Jersey
      • Marlton, New Jersey, Forenede Stater, 08053
        • Hassman Research Institute
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Rutgers University
      • Warren Township, New Jersey, Forenede Stater, 07059
        • IMA Clinical Research Warren
    • New York
      • Binghamton, New York, Forenede Stater, 13905
        • Velocity Clinical Research, Binghamton
      • Buffalo, New York, Forenede Stater, 14203
        • Buffalo Clinical and Translational Research Center
      • Commack, New York, Forenede Stater, 11725
        • Advanced Specialty Care
      • Cortland, New York, Forenede Stater, 13045
        • Smith Allergy and Asthma Specialists
      • East Setauket, New York, Forenede Stater, 11733
        • Stony Brook Medicine Clinical Research Center
      • East Syracuse, New York, Forenede Stater, 13057
        • Upstate Global Health Institute
      • Hampton Bays, New York, Forenede Stater, 11946
        • Southampton Hospital
      • Horseheads, New York, Forenede Stater, 14845
        • Smith Allergy & Asthma Specialists
      • Mineola, New York, Forenede Stater, 11501
        • NYU Langone Hospital - Long Island
      • North Massapequa, New York, Forenede Stater, 11758
        • DiGiovanna Institute for Medical Education & Research
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research, LLC
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University
      • The Bronx, New York, Forenede Stater, 10456
        • Prime Global Research
      • The Bronx, New York, Forenede Stater, 10467
        • Advantage Clinical Trials
      • Vestal, New York, Forenede Stater, 13850
        • Velocity Clinical Research, Vestal
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213
        • Centricity Research Columbus Ohio Multispecialty
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16506
        • Allegheny Health and Wellness Pavilion
      • Erie, Pennsylvania, Forenede Stater, 16508
        • Central Erie Primary Care
      • Pittsburgh, Pennsylvania, Forenede Stater, 15236
        • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
      • Scranton, Pennsylvania, Forenede Stater, 18510
        • Northeast Clinical Trials Group
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29405
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Benchmark Research
      • Fort Worth, Texas, Forenede Stater, 76135
        • Benchmark Research
      • Fort Worth, Texas, Forenede Stater, 76135
        • Texas Health Resources
      • Houston, Texas, Forenede Stater, 77022
        • C & R Research Services USA
      • Houston, Texas, Forenede Stater, 77065
        • DM Clinical Research - Kool Kids Pediatrics
      • Plano, Texas, Forenede Stater, 75093
        • Research Your Health
      • San Antonio, Texas, Forenede Stater, 78215
        • Sun Research Institute
    • Utah
      • West Jordan, Utah, Forenede Stater, 84088
        • Velocity Clinical Research, Salt Lake City
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22902
        • Pediatric Research of Charlottesville, LLC
      • Richmond, Virginia, Forenede Stater, 23226
        • Clinical Research Partners, LLC
    • West Virginia
      • Kingwood, West Virginia, Forenede Stater, 26537
        • Frontier Clinical Research
      • Kingwood, West Virginia, Forenede Stater, 26537
        • Preston Healthcare Services

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 17 år (Barn)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Raske deltagere ved tilmelding, som er fast besluttet på at være berettiget til at blive inkluderet i undersøgelsen. Deltagere med allerede eksisterende kroniske medicinske tilstande, der vurderes at være stabile, kan inkluderes.
  • Deltagere og/eller deltageres forældre/værge, som er villige og i stand til at overholde alle planlagte besøg, undersøgelsesprocedurer og livsstilsovervejelser i hele undersøgelsens varighed.

Ekskluderingskriterier:

  • Kvindelige deltagere, der er gravide, ammer eller har en positiv uringraviditetstest ved besøg 1. Seksuelt aktive kvinder og fertile mænd er uvillige til at bruge prævention i henhold til protokol.
  • Enhver kontraindikation til vaccination eller vaccinekomponenter, herunder tidligere anafylaktisk reaktion på enhver vaccine eller vaccinerelaterede komponenter.
  • Enhver diagnose af Lyme-sygdom inden for de seneste 3 måneder.
  • Enhver historie med Lyme-gigt, carditis, neuroborreliose eller anden spredt borreliose (LD), uanset hvornår den er diagnosticeret.
  • Kendt flåtbid inden for de seneste 4 uger.
  • Medfødt eller erhvervet immundefekt eller andre tilstande eller behandlinger forbundet med immunsuppression, som ville hæmme evnen til at igangsætte et immunrespons på en vaccine.
  • Andre medicinske, psykiatriske tilstande, aktive selvmordstanker/-adfærd eller abnormitet i laboratoriet, som øger risikoen for deltagelse i undersøgelsen eller, efter investigatorens vurdering, er upassende for undersøgelsen.
  • Modtagelse af tidligere vaccination for LD.
  • Behandling for LD i de 3 måneder forud for administration af undersøgelsesintervention.
  • Modtagelse af blod/plasmaprodukter eller immunglobuliner inden for 6 måneder før indgivelse af undersøgelsesintervention gennem afslutning af undersøgelsen.
  • Modtagelse af systemiske kortikosteroider i ≥14 dage inden for 28 dage før administration af undersøgelsesintervention. Inhalerede/nebuliserede, intraartikulære, intrabursale eller topiske kortikosteroider er tilladt.
  • Modtagelse af kronisk systemisk behandling med anden kendt immunsuppressiv medicin eller strålebehandling inden for 6 måneder før administration af undersøgelsesintervention.
  • Aktuel brug af forbudt samtidig medicin eller deltagere, der er uvillige/ude af stand til at bruge en eller flere tilladte samtidige medicin(er).
  • Deltagelse i andre undersøgelser, der involverer forsøgsmedicin/vacciner/udstyr inden for 28 dage før studiestart og/eller under undersøgelsesdeltagelse (observationsundersøgelser er acceptable).
  • Investigator site personale, sponsor/sponsor delegerede direkte involveret i udførelsen af ​​undersøgelsen og deres familiemedlemmer; stedets personale overvåget af efterforskeren og deres familiemedlemmer.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VLA15
Deltagerne vil modtage 6-valent OspA-baseret Lyme-vaccine (VLA15).
Biologisk: VLA15
6-valent OspA-baseret Lyme-vaccine
Andre navne:
  • PF-07307405
Placebo komparator: Normal saltvand (placebo)
Deltagerne vil modtage 0,9 % natriumchloridopløsning til injektion
Andet: Normal saltvand
0,9 % natriumchloridopløsning til injektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 1
Tidsramme: From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 2
Tidsramme: From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 3
Tidsramme: From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
Tidsramme: From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days After Any Study Vaccination
Tidsramme: From Day 1 through Day 7 after any study vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after any study vaccination
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 1
Tidsramme: From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 2
Tidsramme: From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 3
Tidsramme: From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
Tidsramme: From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days After Any Study Vaccination
Tidsramme: From Day 1 through Day 7 after any study vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after any study vaccination
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 1
Tidsramme: From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 2
Tidsramme: From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 3
Tidsramme: From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 4 (Booster Dose)
Tidsramme: From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With AEs Through 1 Month Following Any Study Vaccination
Tidsramme: From Day 1 through 1 Month after any study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this outcome measure.
From Day 1 through 1 Month after any study vaccination
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
Tidsramme: Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
Tidsramme: Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event.
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2022

Primær færdiggørelse (Faktiske)

21. juli 2025

Studieafslutning (Faktiske)

21. juli 2025

Datoer for studieregistrering

Først indsendt

22. november 2022

Først indsendt, der opfyldte QC-kriterier

22. november 2022

Først opslået (Faktiske)

2. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C4601012
  • NCT05634811 (Registry Identifier: ClinicalTrials.gov)
  • 2025-000441-15 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med VLA15

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bahrain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner