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Sikkerhetsstudie av en vaksine for å beskytte mot Lyme-sykdom hos friske barn

14. april 2026 oppdatert av: Pfizer

EN FASE 3, RANDOMISERT, PLACEBO-KONTROLLERT, OBSERVATØRBLINDET FORSØK FOR Å VURDERE SIKKERHETEN TIL EN 6-VALENT OspA-BASERT LYME-SYKDOMSVAKSINE (VLA15) HOS FRISKE BARN FRA 5 TIL 17 ÅR

Denne studien skal forstå om studievaksinen (kalt VLA15) er trygg hos friske barn.

Vi ser etter barn som:

  • er sunne
  • er i alderen 5 til 17
  • har ikke blitt diagnostisert med noen form for borreliose tidligere
  • har ikke fått noen vaksiner mot borreliose tidligere

Lyme sykdom forekommer oftest hos barn i denne alderen. Studievaksinen kan potensielt brukes til å forhindre borreliose. Målet med denne studien er å få mer informasjon om sikkerheten til studievaksinen i denne aldersgruppen.

Deltakerne vil være med i denne studien i ca. 2 år. I løpet av den tiden vil de få VLA15 eller placebo (steril saltvannsløsning) ved et "skudd" i armen. Vi vil sammenligne erfaring med barn som får VLA15 med de som får placebo. Deltakerne vil ikke vite om de får VLA15 eller placebo.

Alle som deltar i denne studien vil:

  • få skuddene på en klinikk eller på et sykehuskontor
  • motta totalt 4 skudd
  • motta de første 3 skuddene innen 6 måneder
  • motta det siste skuddet ca 1 år etterpå
  • må komme til prøvestedet for 6 planlagte besøk; 4 av disse er vaksinasjonsbesøk og 2 er oppfølgingsbesøk. Vi vil kontakte deg på telefon 1 gang hvert år i løpet av studiet for å følge med på opplevelsen din. Du kan få ekstra besøk hvis du opplever en alvorlig reaksjon etter en vaksinedose.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

3547

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 17 år (Barn)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Friske deltakere ved påmelding som er fast bestemt på å være kvalifisert for inkludering i studien. Deltakere med allerede eksisterende kroniske medisinske tilstander som er fastslått å være stabile, kan inkluderes.
  • Deltakere og/eller deltakernes foreldre/foresatte som er villige og i stand til å overholde alle planlagte besøk, studieprosedyrer og livsstilshensyn i løpet av studiet.

Ekskluderingskriterier:

  • Kvinnelige deltakere som er gravide, ammer eller har en positiv uringraviditetstest ved besøk 1. Seksuelt aktive kvinner og fertile menn vil ikke bruke prevensjon i henhold til protokollen.
  • Enhver kontraindikasjon mot vaksinasjon eller vaksinekomponenter, inkludert tidligere anafylaktisk reaksjon på vaksine eller vaksinerelaterte komponenter.
  • Enhver diagnose av borreliose i løpet av de siste 3 månedene.
  • Enhver historie med borreliose-artritt, karbetennelse, nevroborreliose eller annen spredt borreliose-sykdom (LD), uavhengig av når den er diagnostisert.
  • Kjent flåttbitt de siste 4 ukene.
  • Medfødt eller ervervet immunsvikt eller andre tilstander eller behandlinger assosiert med immunsuppresjon som vil hemme evnen til å sette i gang en immunrespons på en vaksine.
  • Andre medisinske, psykiatriske tilstander, aktive selvmordstanker/-adferd eller laboratorieavvik som øker risikoen for studiedeltakelse eller, etter etterforskerens vurdering, er upassende for studien.
  • Mottak av tidligere vaksinasjon for LD.
  • Behandling for LD i 3 måneder før studieintervensjonsadministrasjon.
  • Mottak av blod/plasmaprodukter eller immunglobuliner innen 6 måneder før studieintervensjonsadministrasjon gjennom avslutning av studien.
  • Mottak av systemiske kortikosteroider i ≥14 dager innen 28 dager før administrasjon av studieintervensjon. Inhalerte/nebuliserte, intraartikulære, intrabursale eller topikale kortikosteroider er tillatt.
  • Mottak av kronisk systemisk behandling med andre kjente immunsuppressive medisiner, eller strålebehandling, innen 6 måneder før administrasjon av studieintervensjon.
  • Gjeldende bruk av forbudt(e) samtidig(e) medisin(er) eller deltakere som ikke vil/ikke kan bruke tillatt(e) samtidig(e) medisin(er).
  • Deltakelse i andre studier som involverer undersøkelsesmedisiner/vaksiner/enheter innen 28 dager før studiestart og/eller under studiedeltakelse (observasjonsstudier er akseptable).
  • Ansatte på etterforskerstedet, sponsor-/sponsordelegater som er direkte involvert i gjennomføringen av studien og deres familiemedlemmer; stedets ansatte overvåket av etterforskeren og deres familiemedlemmer.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VLA15
Deltakerne vil motta 6-valent OspA-basert Lyme sykdom vaksine (VLA15).
Biologisk: VLA15
6-valent OspA-basert Lyme sykdom vaksine
Andre navn:
  • PF-07307405
Placebo komparator: Normal saltvann (placebo)
Deltakerne vil motta 0,9 % natriumkloridoppløsning til injeksjon
Annen: Vanlig saltvann
0,9 % natriumkloridoppløsning til injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. desember 2022

Primær fullføring (Faktiske)

21. juli 2025

Studiet fullført (Faktiske)

21. juli 2025

Datoer for studieregistrering

Først innsendt

22. november 2022

Først innsendt som oppfylte QC-kriteriene

22. november 2022

Først lagt ut (Faktiske)

2. desember 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere