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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 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1860

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Argentina
      • Buenos Aires, Argentina
        • Equipo Ciencia
        • Contacto:
        • Investigador principal:
          • Gonzalo Perez Marc
      • Ciudad Autonoma Buenos Aires, Argentina
        • Helios Salud
        • Contacto:
          • Rosa Bologna
          • Número de teléfono: +541143084300
          • Correo electrónico: bolognar@gmail.com
        • Investigador principal:
          • Rosa Bologna
      • Córdoba, Argentina
      • Mar del Plata, Argentina
        • Clinica del Nino y la Familia de Mar del Plata
        • Contacto:
        • Investigador principal:
          • Ignacio Uriarte
      • Río Cuarto, Argentina
        • Instituto Medico Rio Cuarto
        • Contacto:
        • Investigador principal:
          • Ulises D Andrea Nores
      • San Miguel de Tucumán, Argentina
        • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
        • Contacto:
        • Investigador principal:
          • Adriana E Soto
      • San Miguel de Tucumán, Argentina
        • Hospital del Nino Jesus
        • Contacto:
        • Investigador principal:
          • Conrado J Llapur
  • Estados Unidos
    • Arkansas
      • Jonesboro, Arkansas, Estados Unidos, 72401
        • Children's Clinic of Jonesboro, AR
        • Investigador principal:
          • Kevin Rouse
        • Contacto:
      • Little Rock, Arkansas, Estados Unidos, 72212
        • Applied Research Center of Arkansas
        • Contacto:
        • Investigador principal:
          • Sarah Bone
    • California
      • Huntington Park, California, Estados Unidos, 90255
        • Century Research Institute Inc
        • Investigador principal:
          • Albert Nassir
        • Contacto:
      • Los Angeles, California, Estados Unidos, 90057
        • Matrix Clinical Research
        • Investigador principal:
          • Jose Diaz
        • Contacto:
      • Sacramento, California, Estados Unidos, 95823
        • Center for Clinical Trials of Sacramento, Inc.
        • Investigador principal:
          • Marita Biag
        • Contacto:
          • Marita Biag
          • Número de teléfono: 916-525-3377
          • Correo electrónico: drbiag@cctsac.com
      • West Covina, California, Estados Unidos, 91790
        • Center for Clinical Trials of San Gabriel
        • Investigador principal:
          • Holly Lim
        • Contacto:
          • Holly Lim
          • Número de teléfono: 626-960-4942
          • Correo electrónico: hollylimmd@cs.com
    • Florida
      • Coral Gables, Florida, Estados Unidos, 33134
        • BioMD Clinical Research
        • Investigador principal:
          • Ivo Alonso
        • Contacto:
      • Margate, Florida, Estados Unidos, 33063
        • D&H Pompano Research Center LLC
        • Contacto:
          • Yanetsi Landa Colon
          • Número de teléfono: 786-375-6210
          • Correo electrónico: dryflores@dhnrc.com
        • Investigador principal:
          • Yanetsi Landa Colon
      • Tampa, Florida, Estados Unidos, 33613
        • PAS Research
        • Investigador principal:
          • Teena Hughes
        • Contacto:
    • Idaho
      • Ammon, Idaho, Estados Unidos, 83406
        • Medical Research Partners
        • Investigador principal:
          • Joseph Moore
        • Contacto:
          • Joseph Moore
          • Número de teléfono: 843-722-4112
          • Correo electrónico: jmoore@ifpeds.com
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611-2605
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Investigador principal:
          • William Muller
        • Contacto:
    • Kentucky
      • Bardstown, Kentucky, Estados Unidos, 40004
        • Kentucky Pediatric/ Adult Research
        • Investigador principal:
          • Daniel Finn
        • Contacto:
      • Louisville, Kentucky, Estados Unidos, 40202
        • Norton Childrens Research Institute
        • Contacto:
        • Investigador principal:
          • Daniel Blatt
    • Louisiana
      • Covington, Louisiana, Estados Unidos, 70433
        • Benchmark Research
        • Investigador principal:
          • Sherri Casey
        • Contacto:
      • Haughton, Louisiana, Estados Unidos, 71037
        • ACC Pediatric Research
        • Investigador principal:
          • Stacey Sparks
        • Contacto:
      • Lafayette, Louisiana, Estados Unidos, 70508
        • Velocity Clinical Research, Gulfport
        • Investigador principal:
          • Jibran Atwi
        • Contacto:
    • Missouri
      • Jefferson City, Missouri, Estados Unidos, 65109
        • Jefferson City Medical Group PC
        • Investigador principal:
          • Alfred Johnson
        • Contacto:
          • Alfred Johnson
          • Número de teléfono: 919-998-2279
          • Correo electrónico: ajohnson@jcmg.org
    • Montana
      • Missoula, Montana, Estados Unidos, 59804
        • Boeson Research MSO
        • Investigador principal:
          • Aubrey Remmers
        • Contacto:
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68504
        • Midwest Children's Health Research Institute, LLC
        • Investigador principal:
          • David Meduna
        • Contacto:
      • Lincoln, Nebraska, Estados Unidos, 68505
        • Midwest Children's Health Research Institute, LLC
        • Contacto:
        • Investigador principal:
          • Sue Springman
      • Lincoln, Nebraska, Estados Unidos, 68516
        • Complete Children's Health
        • Contacto:
        • Investigador principal:
          • Alexandra Keating
      • Lincoln, Nebraska, Estados Unidos, 68522-1231
        • Complete Children's Health
        • Investigador principal:
          • Luke Anschutz
        • Contacto:
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Atrium Health
        • Investigador principal:
          • Christine Turley
        • Contacto:
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44121-4243
        • Senders Pediatrics
        • Investigador principal:
          • Shelly Senders
        • Contacto:
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29407
        • Neighbors Clinical Research
        • Investigador principal:
          • John Traynham
        • Contacto:
      • Greenville, South Carolina, Estados Unidos, 29607
        • Tribe Clinical Research LLC/Parkside Pediatrics
        • Investigador principal:
          • Scott Dobson
        • Contacto:
      • Simpsonville, South Carolina, Estados Unidos, 29681
        • Tribe Clinical Research LLC/Parkside Pediatrics
        • Contacto:
        • Investigador principal:
          • Justin Moll
      • Summerville, South Carolina, Estados Unidos, 29486
        • Carolina Family Care
        • Investigador principal:
          • Stephen Stripling
        • Contacto:
          • Stephen Stripling
          • Número de teléfono: 843-518-5642
          • Correo electrónico: stripling@musc.edu
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37208
        • Meharry Medical College
        • Investigador principal:
          • Vladimir Berthaud
        • Contacto:
          • Vladimir Berthaud
          • Número de teléfono: 615-293-5241
          • Correo electrónico: vberthaud@mmc.edu
    • Texas
      • Beaumont, Texas, Estados Unidos, 77706
        • Tekton Research - Beaumont, TX
        • Investigador principal:
          • Robert Bell
        • Contacto:
      • Edinburg, Texas, Estados Unidos, 78539
        • PAS Research
        • Contacto:
        • Investigador principal:
          • Allan Mercado
      • Houston, Texas, Estados Unidos, 77087
        • Pediatric Associates
        • Investigador principal:
          • Martin Yudovich
        • Contacto:
    • Utah
      • Kaysville, Utah, Estados Unidos, 84037
        • Tanner Clinic Kaysville
        • Contacto:
        • Investigador principal:
          • Jason Hoagland
      • Layton, Utah, Estados Unidos, 84041
        • Tanner Clinic Layton Parkway
        • Investigador principal:
          • Brent Eberhard
        • Contacto:
      • Ogden, Utah, Estados Unidos, 84404
        • Ogden Clinic Canyon View
        • Investigador principal:
          • Stephen Bruce
        • Contacto:
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22902
        • Pediatric Research of Charlottesville, LLC
        • Contacto:
          • Paul Wisman
          • Número de teléfono: 434-872-9384
          • Correo electrónico: ppw1954@gmail.com
        • Investigador principal:
          • Paul Wisman
      • Richmond, Virginia, Estados Unidos, 23236
        • Clinical Research Partners, LLC
        • Investigador principal:
          • Richard Bennett
        • Contacto:
    • Wisconsin
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc
        • Contacto:
        • Investigador principal:
          • Keith Pulvermacher
  • Finlandia
      • Espoo, Finlandia
        • Finnish Vaccine Research, Espoo Clinic
        • Contacto:
        • Investigador principal:
          • Benita Ukkonen
      • Helsinki, Finlandia
        • Finnish Vaccine Research, Helsinki South Clinic
        • Contacto:
        • Investigador principal:
          • Santtu Heinonen
      • Jarvenpaa, Finlandia
        • Finnish Vaccine Research, Järvenpää Clinic
        • Investigador principal:
          • Miia Virta
        • Contacto:
          • Miia Virta
          • Número de teléfono: +358504437254
          • Correo electrónico: miia.virta@fvr.fi
      • Kokkola, Finlandia
        • Finnish Vaccine Research, Kokkola Clinic
        • Investigador principal:
          • Satu Kokko
        • Contacto:
          • Satu Kokko
          • Número de teléfono: +358504336253
          • Correo electrónico: satu.kokko@fvr.fi
      • Oulu, Finlandia
        • Finnish Vaccine Research, Oulu Clinic
        • Investigador principal:
          • Satu Kokko
        • Contacto:
          • Satu Kokko
          • Número de teléfono: +358504336253
          • Correo electrónico: satu.kokko@fvr.fi
      • Seinäjoki, Finlandia
        • Finnish Vaccine Research, Seinäjoki Clinic
        • Investigador principal:
          • Hilkka Liitsola
        • Contacto:
      • Tampere, Finlandia
        • Finnish Vaccine Research, Tampere Clinic
        • Investigador principal:
          • Oskari Pitkanen
        • Contacto:
      • Turku, Finlandia
        • Finnish Vaccine Research, Turku Clinic
        • Contacto:
        • Investigador principal:
          • Santtu Heinonen
  • Italia
      • Bari, Italia
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
        • Investigador principal:
          • Silvio Tafuri
        • Contacto:
      • Foggia, Italia
        • Ospedale D'Avanzo
        • Investigador principal:
          • Rosa Prato
        • Contacto:
      • Rome, Italia
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contacto:
        • Investigador principal:
          • Danilo Buonsenso
  • Puerto Rico
      • Corozal, Puerto Rico
        • Centro Clin-PR
        • Contacto:
        • Investigador principal:
          • Hector Acevedo-Denis
  • Taiwán
      • Taichung, Taiwán
        • China Medical University Hospital
        • Contacto:
        • Investigador principal:
          • Kao-Pin Hwang
      • Taichung, Taiwán
        • Taichung Veterans General Hospital
        • Contacto:
          • Hui-Hsien Pan
          • Número de teléfono: +886422012525
          • Correo electrónico: jsee0627@gmail.com
        • Investigador principal:
          • Hui-Hsien Pan
      • Taipei, Taiwán
        • National Taiwan University Hospital
        • Contacto:
        • Investigador principal:
          • Li-Min Huang
      • Taipei, Taiwán
        • MacKay Memorial Hospital Taipei Branch
        • Contacto:
        • Investigador principal:
          • Nan-Chang Chiu
      • Taoyuan City, Taiwán
        • Chang Gung Memorial Hospital, Linkou
        • Contacto:
        • Investigador principal:
          • Cheng-Hsun Chiu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Biológico: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biológico: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Otros nombres:
  • 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.
Biológico: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biológico: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Otros nombres:
  • 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.
Biológico: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biológico: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Otros nombres:
  • Kinrix
Comparador activo: MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
Biológico: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Otros nombres:
  • Kinrix
Biológico: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Otros nombres:
  • ProQuad

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

11 de agosto de 2026

Finalización primaria (Estimado)

27 de junio de 2028

Finalización del estudio (Estimado)

21 de noviembre de 2028

Fechas de registro del estudio

Enviado por primera vez

29 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2026

Publicado por primera vez (Actual)

3 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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