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

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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1860

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

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

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

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

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
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • Kinrix
Eksperimentel: 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.
Andre navne:
  • Kinrix
Eksperimentel: 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.
Andre navne:
  • 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.
Andre navne:
  • Kinrix
Biologisk: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Andre navne:
  • ProQuad

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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 (Anslået)

11. august 2026

Primær færdiggørelse (Anslået)

27. juni 2028

Studieafslutning (Anslået)

21. november 2028

Datoer for studieregistrering

Først indsendt

29. juli 2026

Først indsendt, der opfyldte QC-kriterier

29. juli 2026

Først opslået (Faktiske)

3. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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 .

Abonner