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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1860

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 navn:
  • Kinrix
Eksperimentell: 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 navn:
  • Kinrix
Eksperimentell: 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 navn:
  • 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 navn:
  • Kinrix
Biologisk: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Andre navn:
  • ProQuad

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

11. august 2026

Primær fullføring (Antatt)

27. juni 2028

Studiet fullført (Antatt)

21. november 2028

Datoer for studieregistrering

Først innsendt

29. juli 2026

Først innsendt som oppfylte QC-kriteriene

29. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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