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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 3750 participants recherchés46 sites8 pays

Catégories

Maladies infectieuses100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Chickenpox

Éligibilité

SexeTous
Âges12 Months – 15 Months
Volontaires sainsOui

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalPREVENTION
InsuDOUBLE (2)
Recrutement750 participants recherchés

Promoteur et collaborateurs

  • GlaxoSmithKline Promoteur

Groupes et interventions

  • 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.

Interventions

  • Produit biologique Hepatitis A vaccine

    1 dose of hepatitis A vaccine co-administered intramuscularly.

  • Produit biologique Investigational varicella vaccine

    1 dose of investigational varicella vaccine administered subcutaneously.

  • Produit biologique Marketed varicella vaccine

    1 dose of marketed varicella vaccine administered subcutaneously.

  • Produit biologique Measles, mumps, and rubella vaccine

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

  • Produit biologique 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.

  • Produit biologique 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.

  • Produit biologique 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.

Critères de jugement

  1. Critère de jugement principal

    Percentage of participants reporting each solicited administration site events

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

    Délai Day 1 (post-dose) to Day 4

  2. Critère de jugement principal

    Percentage of participants reporting each solicited systemic event

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

    Délai Day 1 (post-dose) to Day 15

  3. Critère de jugement 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).

    Délai Day 1 (post-dose) to Day 22

  4. Critère de jugement principal

    Percentage of participants reporting each solicited administration site events

    Solicited administration site include injection site varicella-like rash.

    Délai Day 1 (post-dose) to Day 43

  5. Critère de jugement principal

    Percentage of participants reporting solicited systemic events

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

    Délai Day 1 (post-dose) to Day 43

  6. Critère de jugement 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.

    Délai Day 1 (post-dose) to Day 43

  7. Critère de jugement 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.

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

  8. Critère de jugement 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.

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

Dates

Date de début26 novembre 2024 (réelle)
Achèvement principal23 novembre 2026 (estimée)
Achèvement23 novembre 2026 (estimée)
Première publication18 novembre 2024 (réelle)
Dernière mise à jour29 mai 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foismai 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

37 sites sont en recrutement

Bulgaria

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteBurgasRetiré
GSK Investigational SiteGabrovoEn recrutement
GSK Investigational SiteKyustendilEn recrutement
GSK Investigational SitePlovdivEn recrutement
GSK Investigational SiteRousseEn recrutement
GSK Investigational SiteSevlievoEn recrutement
GSK Investigational SiteYambolRetiré

Denmark

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteAarhus NEn recrutement
GSK Investigational SiteCopenhagenEn recrutement
GSK Investigational SiteHvidovreEn recrutement
GSK Investigational SiteOdense CEn recrutement

Estonia

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteTallinnEn recrutement
GSK Investigational SiteTallinnEn recrutement

Hong Kong

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteHong KongEn recrutement
GSK Investigational SiteShatinEn recrutement

Lithuania

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteKaunasEn recrutement
GSK Investigational SiteKaunasEn recrutement

Mexico

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteDurangoEn recrutement
GSK Investigational SiteTlalpanEn recrutement
GSK Investigational SiteTlalpanEn recrutement

Poland

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteBydgoszczEn recrutement
GSK Investigational SiteTrzebnicaEn recrutement
GSK Investigational SiteWarsawEn recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
GSK Investigational SiteChicagoIllinoisEn recrutement
GSK Investigational SiteCincinnatiOhioEn recrutement
GSK Investigational SiteDallasTexasRetiré
GSK Investigational SiteDallasTexasEn recrutement
GSK Investigational SiteEl DoradoKansasRetiré
GSK Investigational SiteHialeahFloridaEn recrutement
GSK Investigational SiteHoustonTexasEn recrutement
GSK Investigational SiteHuntington ParkCaliforniaEn recrutement
GSK Investigational SiteLafayetteLouisianaEn recrutement
GSK Investigational SiteLincolnNebraskaEn recrutement
GSK Investigational SiteMankatoMinnesotaEn recrutement
GSK Investigational SiteMiamiFloridaEn recrutement
GSK Investigational SiteNational CityCaliforniaEn recrutement
GSK Investigational SitePhoenixArizonaRetiré
GSK Investigational SiteRichmondTexasEn recrutement
GSK Investigational SiteRichmondVirginiaEn recrutement
GSK Investigational SiteRichmondTexasEn recrutement
GSK Investigational SiteRoyUtahTerminé
GSK Investigational SiteSan AntonioTexasRetiré
GSK Investigational SiteSyracuseUtahEn recrutement
GSK Investigational SiteTucsonArizonaRetiré
GSK Investigational SiteViennaVirginiaRetiré
GSK Investigational SiteWest CovinaCaliforniaEn recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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