Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Undersøgelse af infektionsevnen, sikkerheden og immunogeniciteten af ​​to rekombinante, levende svækkede, B/HPIV3 vektorerede vacciner, der udtrykker fusionsglycoproteinet af HMPV leveret med næsespray til HPIV3-seropositive børn 24 til

21. august 2026 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Fase I-undersøgelse af infektionsevnen, sikkerheden og immunogeniciteten af ​​to rekombinante, levende svækkede, bovine/humane, parainfluenzavirus type 3 (B/HPIV3) vektorerede vacciner, der udtrykker fusionsglycoproteinet fra humant metapneumovirus (HMPV), leveret med næsespray til HPIV3 -Seropositive Børn 24 til

HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to < 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received.

The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children.

The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180.

Additional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This is a blinded, randomized, placebo-controlled study design will be used to evaluate the safety and immunogenicity of the study product in HPIV3-seropositive participants. The study will be performed in approximately 25 HPIV3-seropositive children ≥ 24 months to < 60 months of age. Subjects will be block randomized to receive a single dose of 10^5.6 PFU of B/HPIV3/HMPV-PreF-A, 10^5.6 PFU of B/HPIV3/HMPV-F-B365, or placebo in a 2:2:1 ratio. Enrollment will be continuous unless stopping rules are met or other safety concerns occur. During the enrollment period, the Data and Safety Monitoring Board (DSMB) will perform unblinded safety reviews. After completion of the Day 28 visit of the last participant, an unblinded review of all participants will be performed by the DSMB.

The first 28 days after inoculation are considered the Acute Phase of the study, and the participants' parents/guardians will be contacted daily during the Acute Phase. These contacts will consist either of an in-person evaluation of interim medical history, clinical assessment, and nasal swab, or an interim medical history conducted by a mutually agreed upon communication method. If a child develops a respiratory or febrile illness or otitis media during the acute phase, an in-person evaluation will be performed. During the Acute Phase, the participants will be evaluated for adverse events (AEs) or serious adverse events (SAEs). Between Days 29 and 180 parents/guardians will be asked to contact study staff to report Medically Attended Adverse Events (MAAEs), which will be reported per protocol. Between days 29-180, study staff will contact the participants' parents/guardians monthly and on Day 180 (±7 days) after inoculation to capture any previously unreported MAAEs.

Clinical assessments will be completed and nasal swabs will be obtained on study Days 0, 3, 4, 5, 6, 7, 10, 14 and 28 and whenever febrile or respiratory illnesses or otitis media (solicited AEs) are reported during the first 28 days following inoculation. The nasal swab will be tested for vaccine virus, for respiratory pathogens that are considered adventitious agents, including wild-type HPIV3 and HMPV, and for mucosal IgG and IgA antibody as listed in the schedule of events.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
24

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • CIR - Rangos, Johns Hopkins Bloomberg School of Public Health
      • Columbia, Maryland, Forenede Stater, 21045
        • CIR South
    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester Medical Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

2 år til 4 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ≥24 months of age and <60 months of age at the time of inoculation
  • HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation
  • Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer >1:8
  • Pre-inoculation serum sample for HPIV3-neutralizing antibody specimen is obtained no more than 42 days prior to inoculation
  • In good health based on review of the medical record, history, and physical examination at the time of inoculation
  • Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
  • Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age
  • Expected to be available for the duration of the study
  • Parent/guardian is willing and able to provide written informed consent

Exclusion Criteria:

  • <24 months of age and >60 months of age at the time of inoculation.

  • Born at less than 34 weeks gestation

  • Maternal history of a positive HIV test before or during pregnancy.

  • Evidence of chronic disease

  • Known or suspected infection or impairment of immunological functions

  • Bone marrow/solid organ transplant recipient

  • Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities

  • Suspected or documented developmental disorder, delay, or other developmental problem

  • Cardiac abnormality requiring treatment

  • Lung disease or reactive airway disease

  • More than one episode of medically diagnosed wheezing in the first year of life

  • Wheezing episode or received bronchodilator therapy or racemic epinephrine within the past 12 months

  • Wheezing episode or received bronchodilator therapy after the age of 12 months

  • Previous receipt of supplemental oxygen therapy in a home setting

  • Previous receipt of an investigational HPIV3 or HMPV vaccine

  • Previous receipt or planned administration of human immunoglobulin within the past 6 months. Receipt of licensed monoclonal antibody products for passive prophylaxis against RSV (e.g., nirsevimab) within the past 6 months is not a cause for exclusion

  • Previous receipt of any blood products within the past 6 months.

  • Previous anaphylactic reaction

  • Previous vaccine-associated adverse reaction that was Grade 3 or above.

  • Known hypersensitivity to any study product component

  • Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation

  • Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to:

    • a person who is HIV-infected
    • a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
    • a person living with a solid organ or bone marrow transplant

  • Attends a daycare facility that does not separate children by age and contains a child <12 months of age at the date of inoculation through the 10th day after inoculation

  • Receipt of any of the following prior to enrollment:

    • inactivated influenza vaccine within 3 days prior, or
    • any other inactivated vaccine, messenger RNA (mRNA) vaccine, or live-attenuated rotavirus vaccine within the 14 days prior, or
    • any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
    • another investigational vaccine or investigational drug within 28 days prior, or
    • salicylate (aspirin) or salicylate-containing products within the past 28 days

  • Scheduled administration of any of the following after planned inoculation:

    • inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
    • any live vaccine other than rotavirus within the 28 days after, or
    • any salicylate or salicylate-containing products within the 28 days after, or
    • another investigational vaccine or investigational drug in the 56 days after

  • Receipt of any of the following medications within 3 days prior to study enrollment:

    • systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
    • intranasal medications, or
    • other prescription medications except the permitted concomitant medications listed below
    • Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents

  • Any of the following events at the time of enrollment:

    • fever (temporal or rectal temperature of ≥100.4°F), or
    • upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis), or
    • nasal congestion significant enough to interfere with successful inoculation, or
    • otitis media, or
    • contact with a person diagnosed with COVID-19 disease or active SARS-CoV-2 infection within the preceding 10 days

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Aktiv komparator: B/HPIV3/HMPV-PreF-A vaccine

A single dose of intranasal B/HPIV3/HMPV-PreF-A will be administered by a Vax300 VaxINator atomization device.
Biologisk: B/HPIV3/HMPV-PreF-A vaccine

B/HPIV3/HMPV-PreF-A is a live-attenuated vaccine candidate. The B/HPIV3/HMPV-PreF-A vaccine is provided in a sterile 2.0-mL cryovial, each containing 0.6 mL of vaccine with a titer of approximately 10^6.7 PFU/mL. The vaccine virus concentrate is diluted with Lactated Ringer's Solution for Injection to a dose of approximately 10^5.6 PFU in a 0.2 mL volume.
Aktiv komparator: B/HPIV3/HMPV-F-B365 vaccine

A single dose of intranasal B/HPIV3/HMPV-F-B365 will be administered by a Vax300 VaxINator atomization device.
Biologisk: B/HPIV3/HMPV-F-B365 vaccine

B/HPIV3/HMPV-F-B365 is a live-attenuated vaccine candidate. The B/HPIV3/HMPV-F-B365 vaccine is provided in a sterile 2.0-mL cryovial, each containing 0.6 mL of vaccine with a titer of approximately 10^6.3 PFU/mL. The vaccine virus concentrate is diluted with Lactated Ringer's Solution for Injection to a dose of approximately 10^5.6 PFU in a 0.2 mL volume.
Placebo komparator: Placebo

A single dose of intranasal Lactated Ringer's Solution for Injection will be administered by a Vax300 VaxINator atomization device.
Medicin: Placebo

Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It will be drawn up in a sterile syringe to a volume of 0.2 mL.

Andre navne:
  • Ringers laktatopløsning til injektion

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Tidsramme: Day 0 through Day 28

Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix II of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 5-death) following protocol-defined grading system outlined in Table 13 and Table 14 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2.
Day 0 through Day 28
Frequency of Lower Respiratory Illness (LRIs) by Grade
Tidsramme: Measured through Day 28

LRI may include wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi and rales as defined in Appendix II of the protocol document. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 5-death) following protocol-defined grading system outlined in Table 13 in the protocol document.
Measured through Day 28
Percentage of Vaccinees With a ≥4-fold Rise in HPIV3 Serum Neutralizing Antibody Titer
Tidsramme: Measured at Day 0 and Day 28

Serum HPIV3-neutralizing antibody titers were assessed by 60% HPIV3-plaque reduction neutralization titer (HPIV3-PRNT) assay. Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
Measured at Day 0 and Day 28
Percentages of Vaccinees With a ≥4-fold Rise in HMPV-neutralizing Serum Antibody Titers
Tidsramme: Measured at Day 0 and Day 28

Serum HMPV-neutralizing antibody titers were assessed by 60% HMPV-plaque reduction neutralization titer (HMPV-PRNT) assay. Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
Measured at Day 0 and Day 28
Peak Titers of Vaccine Virus Shed
Tidsramme: Measured study days 0-28

This is the highest value per participant of the titer of vaccine virus shed. It was measured by RT-qPCR. For the purposes of calculation, peak titers of 1.7 log10 copy number, which is the lower limit of detection of the RT-qPCR assay, were assigned to qPCR negative samples. Note that only 1 participant who received the B/HPIV3/HMPV-PreF-A vaccine and only 1 participant that received the B/HPIV3/HMPV-F-B365 vaccine shed vaccine virus.
Measured study days 0-28
Number of Vaccinees Infected With Vaccine Virus
Tidsramme: Measured through Day 28

Infection with vaccine virus is determined by shedding of vaccine virus detected by immunoplaque assay and/or RT-qPCR, and/or ≥4 fold rise in HPIV3 or HMPV-specific serum antibodies, detected by neutralizing antibody assay or ELISA from study entry to Study Day 28
Measured through Day 28

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency and Severity of Medically Attended Adverse Events (MAAEs) by Grade
Tidsramme: Measured from Day 29 through Day 180 (Observation Period)

The number of participants who had medically attended illness (solicited and unsolicited adverse events). A participant was only counted once in each AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 5-death) following protocol-defined grading system outlined in Table 13 and Table 14 in the protocol document.
Measured from Day 29 through Day 180 (Observation Period)
Number of Participants Who Experienced Serious Adverse Events (SAEs)
Tidsramme: Measured Day 0 through Day 180 after inoculation

A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:

Results in death during the period of protocol-defined surveillance; Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; Results in a persistent or significant disability/incapacity; Is a congenital anomaly or birth defect, OR Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Measured Day 0 through Day 180 after inoculation

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Johns Hopkins Bloomberg School of Public Health
Vanderbilt University Medical Center
University of Rochester

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Ruth Karron, M.D., Center for Immunization Research, JHBSPH

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
12. juli 2024

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
4. juni 2025

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
4. juni 2025

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
6. august 2024

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
6. august 2024

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
9. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
21. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • CIR363

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers may request access to IPD that underlie results in a publication. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

IPD-delingstidsramme

After publication

IPD-delingsadgangskriterier

Qualified researchers

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 .

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