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NCT06693895ClinicalTrials.gov

A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age

A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

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En resumen

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to…

Fase 3750 participantes buscados46 centros8 países

Categorías

Enfermedades infecciosas100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-11-18; recorded start 2024-11-26
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 321 other studies in this databaseCounted from the lead sponsor named in the record (GlaxoSmithKline)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding13/20

    Double-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 46 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 750 participants (target), run at 46 sites, across 8 countries.

How this score is built
  • Enrolment28/40

    750 participants (target)

  • Site count20/25

    46 sites

  • Country count12/15

    8 countries

  • Planned duration7/10

    Planned over about 24 months

  • Sponsor scale9/10

    GlaxoSmithKline has led 305 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.

Afecciones

  • Chickenpox

Elegibilidad

SexoTodos
Edades12 Months – 15 Months
Voluntarios sanosSí

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Participant's parent(s)/Legally acceptable representatives (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). * Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure. * Healthy participants as established by medical history and clinical examination before entering the study. * A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of study interventions. * Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry. Exclusion Criteria: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Hypersensitivity to latex. * Recurrent history of uncontrolled neurological disorders or seizures. * History of varicella disease. * Active untreated tuberculosis * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period. * Planned administration of a vaccine 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 inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions. Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter. * 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 intervention administration: * For corticosteroids, this will mean prednisone equivalent \>= 0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/or any blood products or plasma derivatives. * 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 vaccines, e.g., nirsevimab), antitumoral medication. * Previous vaccination against measles, mumps, and rubella. * Previous vaccination against hepatitis A virus. * Previous vaccination against varicella virus. * Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV. * 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/invasive medical device). * Child in care. * Any study personnel's immediate dependents, family, or household members. * 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 less than (\<) 28 weeks of gestation.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalPREVENTION
EnmascaramientoDOUBLE (2)
Inscripción750 participantes buscados

Patrocinador y colaboradores

  • GlaxoSmithKline Patrocinador

Grupos e intervenciones

  • VNS GroupEXPERIMENTAL

    Participants receive 1 dose of a VNS vaccine, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A (HAV) vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

  • VV GroupACTIVE_COMPARATOR

    Participants receive 1 dose of a marketed VV, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Intervenciones

  • Biológico Hepatitis A vaccine

    1 dose of hepatitis A vaccine co-administered intramuscularly.

  • Biológico Investigational varicella vaccine

    1 dose of investigational varicella vaccine administered subcutaneously.

  • Biológico Marketed varicella vaccine

    1 dose of marketed varicella vaccine administered subcutaneously.

  • Biológico Measles, mumps, and rubella vaccine

    1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.

  • Biológico PCV (pneumococcal conjugate vaccine) 13

    1 dose of 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

  • Biológico PCV 20

    1 dose of 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

  • Biológico Vaxneuvance

    1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

Variables de resultado

  1. Variable de resultado principal

    Percentage of participants reporting each solicited administration site events

    Solicited administration site events include injection site redness, pain and swelling.

    Plazo Day 1 (post-dose) to Day 4

  2. Variable de resultado principal

    Percentage of participants reporting each solicited systemic event

    Solicited systemic events include drowsiness, loss of appetite and irritability.

    Plazo Day 1 (post-dose) to Day 15

  3. Variable de resultado principal

    Percentage of participants reporting each solicited systemic event in terms of fever

    Fever is defined as temperature greater than or equal to (\>=) 38.0°C (100.4°F) by any route (the preferred location for measuring temperature is the axilla).

    Plazo Day 1 (post-dose) to Day 22

  4. Variable de resultado principal

    Percentage of participants reporting each solicited administration site events

    Solicited administration site include injection site varicella-like rash.

    Plazo Day 1 (post-dose) to Day 43

  5. Variable de resultado principal

    Percentage of participants reporting solicited systemic events

    Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).

    Plazo Day 1 (post-dose) to Day 43

  6. Variable de resultado principal

    Percentage of participants reporting unsolicited adverse events (AEs)

    An unsolicited AE is an AE that was 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.

    Plazo Day 1 (post-dose) to Day 43

  7. Variable de resultado principal

    Percentage of participants reporting medically attended AEs (MAAE)

    A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.

    Plazo Day 1 (post-dose) to Day 181 (study end)

  8. Variable de resultado principal

    Percentage of participants reporting serious adverse events (SAEs)

    A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

    Plazo Day 1 (post-dose) to Day 181 (study end)

Fechas

Fecha de inicio26 de noviembre de 2024 (real)
Finalización principal23 de noviembre de 2026 (estimada)
Finalización23 de noviembre de 2026 (estimada)
Primera publicación18 de noviembre de 2024 (real)
Última actualización29 de mayo de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezmayo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

37 centros están en reclutamiento

Bulgaria

CentroCiudadEstado o regiónEstado
GSK Investigational SiteBurgasRetirado
GSK Investigational SiteGabrovoEn reclutamiento
GSK Investigational SiteKyustendilEn reclutamiento
GSK Investigational SitePlovdivEn reclutamiento
GSK Investigational SiteRousseEn reclutamiento
GSK Investigational SiteSevlievoEn reclutamiento
GSK Investigational SiteYambolRetirado

Denmark

CentroCiudadEstado o regiónEstado
GSK Investigational SiteAarhus NEn reclutamiento
GSK Investigational SiteCopenhagenEn reclutamiento
GSK Investigational SiteHvidovreEn reclutamiento
GSK Investigational SiteOdense CEn reclutamiento

Estonia

CentroCiudadEstado o regiónEstado
GSK Investigational SiteTallinnEn reclutamiento
GSK Investigational SiteTallinnEn reclutamiento

Hong Kong

CentroCiudadEstado o regiónEstado
GSK Investigational SiteHong KongEn reclutamiento
GSK Investigational SiteShatinEn reclutamiento

Lithuania

CentroCiudadEstado o regiónEstado
GSK Investigational SiteKaunasEn reclutamiento
GSK Investigational SiteKaunasEn reclutamiento

Mexico

CentroCiudadEstado o regiónEstado
GSK Investigational SiteDurangoEn reclutamiento
GSK Investigational SiteTlalpanEn reclutamiento
GSK Investigational SiteTlalpanEn reclutamiento

Poland

CentroCiudadEstado o regiónEstado
GSK Investigational SiteBydgoszczEn reclutamiento
GSK Investigational SiteTrzebnicaEn reclutamiento
GSK Investigational SiteWarsawEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
GSK Investigational SiteChicagoIllinoisEn reclutamiento
GSK Investigational SiteCincinnatiOhioEn reclutamiento
GSK Investigational SiteDallasTexasRetirado
GSK Investigational SiteDallasTexasEn reclutamiento
GSK Investigational SiteEl DoradoKansasRetirado
GSK Investigational SiteHialeahFloridaEn reclutamiento
GSK Investigational SiteHoustonTexasEn reclutamiento
GSK Investigational SiteHuntington ParkCaliforniaEn reclutamiento
GSK Investigational SiteLafayetteLouisianaEn reclutamiento
GSK Investigational SiteLincolnNebraskaEn reclutamiento
GSK Investigational SiteMankatoMinnesotaEn reclutamiento
GSK Investigational SiteMiamiFloridaEn reclutamiento
GSK Investigational SiteNational CityCaliforniaEn reclutamiento
GSK Investigational SitePhoenixArizonaRetirado
GSK Investigational SiteRichmondTexasEn reclutamiento
GSK Investigational SiteRichmondVirginiaEn reclutamiento
GSK Investigational SiteRichmondTexasEn reclutamiento
GSK Investigational SiteRoyUtahCompletado
GSK Investigational SiteSan AntonioTexasRetirado
GSK Investigational SiteSyracuseUtahEn reclutamiento
GSK Investigational SiteTucsonArizonaRetirado
GSK Investigational SiteViennaVirginiaRetirado
GSK Investigational SiteWest CovinaCaliforniaEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06693895