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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

1860

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Biologisch: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologisch: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andere Namen:
  • Kinrix
Experimental: 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.
Biologisch: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologisch: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andere Namen:
  • Kinrix
Experimental: 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.
Biologisch: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biologisch: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andere Namen:
  • Kinrix
Aktiver Komparator: MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
Biologisch: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Andere Namen:
  • Kinrix
Biologisch: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Andere Namen:
  • ProQuad

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

11. August 2026

Primärer Abschluss (Geschätzt)

27. Juni 2028

Studienabschluss (Geschätzt)

21. November 2028

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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