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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 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

1860

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologique: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Autres noms:
  • Kinrix
Expérimental: 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.
Biologique: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologique: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Autres noms:
  • Kinrix
Expérimental: 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.
Biologique: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologique: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Autres noms:
  • Kinrix
Comparateur actif: MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
Biologique: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Autres noms:
  • Kinrix
Biologique: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Autres noms:
  • ProQuad

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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
Délai: 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
Délai: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

11 août 2026

Achèvement primaire (Estimé)

27 juin 2028

Achèvement de l'étude (Estimé)

21 novembre 2028

Dates d'inscription aux études

Première soumission

29 juillet 2026

Première soumission répondant aux critères de contrôle qualité

29 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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