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A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age (MMRVNS 20-002)

29 juli 2026 uppdaterad av: GlaxoSmithKline

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine Compared With ProQuad, Administered as a Second Dose in Healthy Children 4-6 Years of Age

The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.

The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).

The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1860

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Argentina
      • Buenos Aires, Argentina
        • Equipo Ciencia
        • Kontakt:
        • Huvudutredare:
          • Gonzalo Perez Marc
      • Ciudad Autonoma Buenos Aires, Argentina
        • Helios Salud
        • Kontakt:
        • Huvudutredare:
          • Rosa Bologna
      • Córdoba, Argentina
      • Mar del Plata, Argentina
        • Clinica del Nino y la Familia de Mar del Plata
        • Kontakt:
        • Huvudutredare:
          • Ignacio Uriarte
      • Río Cuarto, Argentina
        • Instituto Medico Rio Cuarto
        • Kontakt:
        • Huvudutredare:
          • Ulises D Andrea Nores
      • San Miguel de Tucumán, Argentina
        • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
        • Kontakt:
        • Huvudutredare:
          • Adriana E Soto
      • San Miguel de Tucumán, Argentina
        • Hospital del Nino Jesus
        • Kontakt:
        • Huvudutredare:
          • Conrado J Llapur
  • Finland
      • Espoo, Finland
        • Finnish Vaccine Research, Espoo Clinic
        • Kontakt:
        • Huvudutredare:
          • Benita Ukkonen
      • Helsinki, Finland
        • Finnish Vaccine Research, Helsinki South Clinic
        • Kontakt:
        • Huvudutredare:
          • Santtu Heinonen
      • Jarvenpaa, Finland
        • Finnish Vaccine Research, Järvenpää Clinic
        • Huvudutredare:
          • Miia Virta
        • Kontakt:
      • Kokkola, Finland
        • Finnish Vaccine Research, Kokkola Clinic
        • Huvudutredare:
          • Satu Kokko
        • Kontakt:
      • Oulu, Finland
        • Finnish Vaccine Research, Oulu Clinic
        • Huvudutredare:
          • Satu Kokko
        • Kontakt:
      • Seinäjoki, Finland
        • Finnish Vaccine Research, Seinäjoki Clinic
        • Huvudutredare:
          • Hilkka Liitsola
        • Kontakt:
      • Tampere, Finland
        • Finnish Vaccine Research, Tampere Clinic
        • Huvudutredare:
          • Oskari Pitkanen
        • Kontakt:
      • Turku, Finland
        • Finnish Vaccine Research, Turku Clinic
        • Kontakt:
        • Huvudutredare:
          • Santtu Heinonen
  • Förenta staterna
    • Arkansas
      • Jonesboro, Arkansas, Förenta staterna, 72401
        • Children's Clinic of Jonesboro, AR
        • Huvudutredare:
          • Kevin Rouse
        • Kontakt:
      • Little Rock, Arkansas, Förenta staterna, 72212
        • Applied Research Center of Arkansas
        • Kontakt:
        • Huvudutredare:
          • Sarah Bone
    • California
      • Huntington Park, California, Förenta staterna, 90255
        • Century Research Institute Inc
        • Huvudutredare:
          • Albert Nassir
        • Kontakt:
      • Los Angeles, California, Förenta staterna, 90057
        • Matrix Clinical Research
        • Huvudutredare:
          • Jose Diaz
        • Kontakt:
      • Sacramento, California, Förenta staterna, 95823
        • Center for Clinical Trials of Sacramento, Inc.
        • Huvudutredare:
          • Marita Biag
        • Kontakt:
      • West Covina, California, Förenta staterna, 91790
        • Center for Clinical Trials of San Gabriel
        • Huvudutredare:
          • Holly Lim
        • Kontakt:
    • Florida
      • Coral Gables, Florida, Förenta staterna, 33134
      • Margate, Florida, Förenta staterna, 33063
        • D&H Pompano Research Center LLC
        • Kontakt:
        • Huvudutredare:
          • Yanetsi Landa Colon
      • Tampa, Florida, Förenta staterna, 33613
        • PAS Research
        • Huvudutredare:
          • Teena Hughes
        • Kontakt:
    • Idaho
      • Ammon, Idaho, Förenta staterna, 83406
        • Medical Research Partners
        • Huvudutredare:
          • Joseph Moore
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611-2605
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Huvudutredare:
          • William Muller
        • Kontakt:
    • Kentucky
      • Bardstown, Kentucky, Förenta staterna, 40004
        • Kentucky Pediatric/ Adult Research
        • Huvudutredare:
          • Daniel Finn
        • Kontakt:
      • Louisville, Kentucky, Förenta staterna, 40202
        • Norton Childrens Research Institute
        • Kontakt:
        • Huvudutredare:
          • Daniel Blatt
    • Louisiana
      • Covington, Louisiana, Förenta staterna, 70433
        • Benchmark Research
        • Huvudutredare:
          • Sherri Casey
        • Kontakt:
      • Haughton, Louisiana, Förenta staterna, 71037
        • ACC Pediatric Research
        • Huvudutredare:
          • Stacey Sparks
        • Kontakt:
      • Lafayette, Louisiana, Förenta staterna, 70508
        • Velocity Clinical Research, Gulfport
        • Huvudutredare:
          • Jibran Atwi
        • Kontakt:
    • Missouri
      • Jefferson City, Missouri, Förenta staterna, 65109
        • Jefferson City Medical Group PC
        • Huvudutredare:
          • Alfred Johnson
        • Kontakt:
    • Montana
      • Missoula, Montana, Förenta staterna, 59804
    • Nebraska
      • Lincoln, Nebraska, Förenta staterna, 68504
        • Midwest Children's Health Research Institute, LLC
        • Huvudutredare:
          • David Meduna
        • Kontakt:
      • Lincoln, Nebraska, Förenta staterna, 68505
        • Midwest Children's Health Research Institute, LLC
        • Kontakt:
        • Huvudutredare:
          • Sue Springman
      • Lincoln, Nebraska, Förenta staterna, 68516
        • Complete Children's Health
        • Kontakt:
        • Huvudutredare:
          • Alexandra Keating
      • Lincoln, Nebraska, Förenta staterna, 68522-1231
        • Complete Children's Health
        • Huvudutredare:
          • Luke Anschutz
        • Kontakt:
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28203
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44121-4243
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29407
        • Neighbors Clinical Research
        • Huvudutredare:
          • John Traynham
        • Kontakt:
      • Greenville, South Carolina, Förenta staterna, 29607
        • Tribe Clinical Research LLC/Parkside Pediatrics
        • Huvudutredare:
          • Scott Dobson
        • Kontakt:
      • Simpsonville, South Carolina, Förenta staterna, 29681
        • Tribe Clinical Research LLC/Parkside Pediatrics
        • Kontakt:
        • Huvudutredare:
          • Justin Moll
      • Summerville, South Carolina, Förenta staterna, 29486
        • Carolina Family Care
        • Huvudutredare:
          • Stephen Stripling
        • Kontakt:
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37208
        • Meharry Medical College
        • Huvudutredare:
          • Vladimir Berthaud
        • Kontakt:
    • Texas
      • Beaumont, Texas, Förenta staterna, 77706
        • Tekton Research - Beaumont, TX
        • Huvudutredare:
          • Robert Bell
        • Kontakt:
      • Edinburg, Texas, Förenta staterna, 78539
      • Houston, Texas, Förenta staterna, 77087
        • Pediatric Associates
        • Huvudutredare:
          • Martin Yudovich
        • Kontakt:
    • Utah
      • Kaysville, Utah, Förenta staterna, 84037
      • Layton, Utah, Förenta staterna, 84041
      • Ogden, Utah, Förenta staterna, 84404
        • Ogden Clinic Canyon View
        • Huvudutredare:
          • Stephen Bruce
        • Kontakt:
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22902
        • Pediatric Research of Charlottesville, LLC
        • Kontakt:
        • Huvudutredare:
          • Paul Wisman
      • Richmond, Virginia, Förenta staterna, 23236
    • Wisconsin
      • Marshfield, Wisconsin, Förenta staterna, 54449
        • Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc
        • Kontakt:
        • Huvudutredare:
          • Keith Pulvermacher
  • Italien
      • Bari, Italien
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
        • Huvudutredare:
          • Silvio Tafuri
        • Kontakt:
      • Foggia, Italien
        • Ospedale D'Avanzo
        • Huvudutredare:
          • Rosa Prato
        • Kontakt:
      • Rome, Italien
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Kontakt:
        • Huvudutredare:
          • Danilo Buonsenso
  • Puerto Rico
      • Corozal, Puerto Rico
  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital
        • Kontakt:
        • Huvudutredare:
          • Kao-Pin Hwang
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
        • Kontakt:
        • Huvudutredare:
          • Hui-Hsien Pan
      • Taipei, Taiwan
        • National Taiwan University Hospital
        • Kontakt:
        • Huvudutredare:
          • Li-Min Huang
      • Taipei, Taiwan
        • MacKay Memorial Hospital Taipei Branch
        • Kontakt:
        • Huvudutredare:
          • Nan-Chang Chiu
      • Taoyuan City, Taiwan
        • Chang Gung Memorial Hospital, Linkou
        • Kontakt:
        • Huvudutredare:
          • Cheng-Hsun Chiu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria (INC):

  • INC#1 Participant's parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
  • INC#2 Written or witnessed/thumb printed or digital informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study specific procedure.
  • INC#3 Informed assent obtained from the participants in line with local rules and regulations.
  • INC#4 Healthy participants as established by medical history and clinical examination at screening.
  • INC#5 A male or female participant between and including 4 and 6 years of age (i.e., from fourth birthday until the day before the seventh birthday) at the time of the study interventions administration, and in accordance with local regulations.
  • INC#6 Participant who previously received a first dose of varicella-containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
  • INC#7 Participant who previously received a first dose of measles, mumps, rubella containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
  • INC#8 Participant who previously received 3 or 4 doses of any combined DTP (DTaP/DTwP) vaccine (diphtheria and tetanus toxoids and pertussis antigens whether or not combined with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b antigens) according to the local recommendations.

Exclusion Criteria (EXC):

  • EXC#1 History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or gelatin.
  • EXC#2 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • EXC#3 Hypersensitivity to latex.
  • EXC#4 Unstable chronic conditions as determined by medical history and physical examination.
  • EXC#5 Major congenital defects, as assessed by the investigator.
  • EXC#6 History of measles, mumps, rubella or varicella/zoster disease as evaluated by the investigator.
  • EXC#7 History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
  • EXC#8 Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures (including all subtypes, such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures).
  • EXC#9 Active untreated tuberculosis.
  • EXC#10 Condition that, in the judgment of the investigator, would make intramuscular injection unsafe.
  • EXC#11 Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
  • EXC#12 Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
  • EXC#13 Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.

  • EXC#14 Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.

    • Up to 90 days prior to the study interventions administration.

      • For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled, intra-articular/intra-bursal and topical steroids are allowed.
    • Up to 180 days prior to study interventions administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study interventions, e.g., nirsevimab), antitumoral medication.
  • EXC#15 Previous vaccination with a second dose of varicella-containing vaccine or measles, mumps, rubella containing vaccine.
  • EXC#16 Vaccination against diphtheria, tetanus, pertussis, and/or poliomyelitis given after the second year of life (i.e., after the second birthday at 24 months of age).

  • EXC#17 Occurrence of any of the following events after a previous administration of DTP vaccine:

    • Encephalopathy of unknown etiology occurring during the period starting within 7 days of vaccination of a previous administration of DTP vaccine.
    • A temperature (≥40.6°C [≥105°F]) during the period starting 48 hours after vaccination not due to another identifiable cause.
  • EXC#18 Use of salicylates (aspirin) or salicylate-containing products or its planned use, during the period of 6 weeks following study interventions administration.
  • EXC#19 Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration* (Visit 2), with the exception of

Influenza vaccines:

  • Inactivated influenza vaccine must not be administered in the period starting 28 days before the dose and ending 28 days after the dose of study intervention administration. If administered outside this prohibited period, it should be administered at a different location than the study intervention.

  • Live attenuated influenza vaccine must not be administered during the period starting 30 days before the dose and ending 43 days after the dose of study intervention administration (Visit 2).

    • If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.

      • EXC#20 Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/vaccine/invasive medical device).
      • EXC#21 Any study personnel's immediate dependents, family, or household members.
      • EXC#22 Child in care.

      • EXC#23 Participants with the following high-risk individuals in their household:

        • Immunocompromised individuals.
        • Pregnant women without documented history of varicella.
        • Newborn infants of mothers without documented history of varicella.
        • Newborn infants born <28 weeks of gestation.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MMRVNS_Lot 1 group
Participants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Biologisk: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologisk: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andra namn:
  • Kinrix
Experimentell: MMRVNS_Lot 2 group
Participants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Biologisk: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologisk: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andra namn:
  • Kinrix
Experimentell: MMRVNS_Lot 3 group
Participants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Biologisk: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologisk: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andra namn:
  • Kinrix
Aktiv komparator: MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
Biologisk: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andra namn:
  • Kinrix
Biologisk: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Andra namn:
  • ProQuad

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Geometric mean concentrations (GMCs) of immunoglobulin G (IgG) antibodies against measles, mumps, rubella, and varicella zoster virus (VZV) glycoprotein E (gE) after MMRVNS vaccine administration
Tidsram: At Day 43
This outcome measure evaluates immunological consistency.
At Day 43
Number of participants with seroresponse against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration
Tidsram: At Day 43

This outcome measure evaluates immunological non-inferiority.

Seroresponse is defined as post-vaccination IgG antibody concentrations equal to or above threshold values as follows:

The seroresponse of a participant is:

  • zero (non-seroresponder) if the IgG concentration is below the seroresponse threshold of the assay,
  • One (seroresponder) if the IgG concentration is above or equal to the seroresponse threshold.
At Day 43
GMCs of IgG concentrations against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration
Tidsram: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
GMCs of IgG antibodies against diphtheria, tetanus, and pertussis antigens (Bordetella pertussis toxin, filamentous hemagglutinin, and outer membrane protein pertactin) after MMRVNS or MMRV administration in a subset of participants
Tidsram: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43
Geometric mean titers (GMTs) of neutralizing antibodies against poliovirus 1, 2, and 3 after MMRVNS or MMRV administration in a subset of participants
Tidsram: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43
Booster response of IgG concentrations against pertussis antigens (Bordetella pertussis toxin, filamentous hemagglutinin, and outer membrane pertactin) after DTaP-IPV co-administration with MMRVNS or MMRV in a subset of participants
Tidsram: At Day 43

The booster response of a participant is:

One (responder) if:

- the pre-vaccination antibody concentration is below the assay cut-off, and the post-vaccination antibody concentration is >=4 times the assay cut-off.

or, - the pre-vaccination antibody concentration is between the assay cut-off and 4 times the assay cut-off, and the post-vaccination antibody concentration is >=4 times the pre vaccination antibody concentration.

or,

- the pre-vaccination antibody concentration is greater or equal to 4 times the assay cut-off, and the post vaccination antibody concentration is >=2 times the pre-vaccination antibody concentration.

Zero (non-responder) in all other cases.
At Day 43
Number of participants with any solicited administration site events following MMRVNS or MMRV administration
Tidsram: From Day 1 to Day 4 for injection site redness, pain/tenderness, and swelling; and from Day 1 to Day 43 for injection site varicella-like rash
Solicited administration site events are injection site redness, pain/tenderness, swelling, and injection site varicella-like rash.
From Day 1 to Day 4 for injection site redness, pain/tenderness, and swelling; and from Day 1 to Day 43 for injection site varicella-like rash
Number of participants with any solicited systemic events following MMRVNS or MMRV administration
Tidsram: From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; Day 1 to Day 43 for varicella-like rash (non-injection site), measles/rubella-like rash, and other rash
Solicited systemic events are somnolence (sleepiness/drowsiness), loss of appetite, fever, varicella-like rash (non-injection site), measles/rubella-like rash, and other rash that is not varicella-like or measles/rubella-like rash.
From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; Day 1 to Day 43 for varicella-like rash (non-injection site), measles/rubella-like rash, and other rash
Number of participants with any unsolicited adverse events (AEs) following MMRVNS or MMRV administration
Tidsram: From Day 1 to Day 43
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events.
From Day 1 to Day 43
Number of participants with any medically attended adverse events (MAAEs) following MMRVNS or MMRV administration
Tidsram: From Day 1 to Day 181
MAAEs are solicited AEs and unsolicited nonserious AEs for which the participant received medical attention (an unscheduled visit to or from medical personnel for any reason, including emergency room visits).
From Day 1 to Day 181
Number of participants with serious adverse events (SAEs), fatal SAEs, and related SAEs following MMRVNS or MMRV administration
Tidsram: From Day 1 to Day 181
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or other medically significant events.
From Day 1 to Day 181

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

11 augusti 2026

Primärt slutförande (Beräknad)

27 juni 2028

Avslutad studie (Beräknad)

21 november 2028

Studieregistreringsdatum

Först inskickad

29 juli 2026

Först inskickad som uppfyllde QC-kriterierna

29 juli 2026

Första postat (Faktisk)

3 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 217717
  • 2025-523277-42-00 (Ctis)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Tidsram för IPD-delning

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Kriterier för IPD Sharing Access

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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