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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 750 משתתפים46 אתרים8 מדינות

קטגוריות

מחלות זיהומיות100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Chickenpox

זכאות

מיןהכול
גילאים12 Months – 15 Months
מתנדבים בריאיםכן

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתPREVENTION
הסתרהDOUBLE (2)
גיוסדרושים 750 משתתפים

נותן חסות ושותפים

  • GlaxoSmithKline נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • ביולוגי Hepatitis A vaccine

    1 dose of hepatitis A vaccine co-administered intramuscularly.

  • ביולוגי Investigational varicella vaccine

    1 dose of investigational varicella vaccine administered subcutaneously.

  • ביולוגי Marketed varicella vaccine

    1 dose of marketed varicella vaccine administered subcutaneously.

  • ביולוגי Measles, mumps, and rubella vaccine

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

  • ביולוגי 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.

  • ביולוגי 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.

  • ביולוגי 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.

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Percentage of participants reporting each solicited administration site events

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

    מסגרת זמן Day 1 (post-dose) to Day 4

  2. מדד תוצאה ראשוני

    Percentage of participants reporting each solicited systemic event

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

    מסגרת זמן Day 1 (post-dose) to Day 15

  3. מדד תוצאה ראשוני

    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).

    מסגרת זמן Day 1 (post-dose) to Day 22

  4. מדד תוצאה ראשוני

    Percentage of participants reporting each solicited administration site events

    Solicited administration site include injection site varicella-like rash.

    מסגרת זמן Day 1 (post-dose) to Day 43

  5. מדד תוצאה ראשוני

    Percentage of participants reporting solicited systemic events

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

    מסגרת זמן Day 1 (post-dose) to Day 43

  6. מדד תוצאה ראשוני

    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.

    מסגרת זמן Day 1 (post-dose) to Day 43

  7. מדד תוצאה ראשוני

    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.

    מסגרת זמן Day 1 (post-dose) to Day 181 (study end)

  8. מדד תוצאה ראשוני

    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.

    מסגרת זמן Day 1 (post-dose) to Day 181 (study end)

תאריכים

תאריך התחלה26 בנובמבר 2024 (בפועל)
סיום ראשוני23 בנובמבר 2026 (משוער)
סיום23 בנובמבר 2026 (משוער)
פורסם לראשונה18 בנובמבר 2024 (בפועל)
עודכן לאחרונה29 במאי 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהמאי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

37 אתרים מגייסים

Bulgaria

מתקןעירמדינה או אזורמצב
GSK Investigational SiteBurgasבוטל
GSK Investigational SiteGabrovoמגייס
GSK Investigational SiteKyustendilמגייס
GSK Investigational SitePlovdivמגייס
GSK Investigational SiteRousseמגייס
GSK Investigational SiteSevlievoמגייס
GSK Investigational SiteYambolבוטל

Denmark

מתקןעירמדינה או אזורמצב
GSK Investigational SiteAarhus Nמגייס
GSK Investigational SiteCopenhagenמגייס
GSK Investigational SiteHvidovreמגייס
GSK Investigational SiteOdense Cמגייס

Estonia

מתקןעירמדינה או אזורמצב
GSK Investigational SiteTallinnמגייס
GSK Investigational SiteTallinnמגייס

Hong Kong

מתקןעירמדינה או אזורמצב
GSK Investigational SiteHong Kongמגייס
GSK Investigational SiteShatinמגייס

Lithuania

מתקןעירמדינה או אזורמצב
GSK Investigational SiteKaunasמגייס
GSK Investigational SiteKaunasמגייס

Mexico

מתקןעירמדינה או אזורמצב
GSK Investigational SiteDurangoמגייס
GSK Investigational SiteTlalpanמגייס
GSK Investigational SiteTlalpanמגייס

Poland

מתקןעירמדינה או אזורמצב
GSK Investigational SiteBydgoszczמגייס
GSK Investigational SiteTrzebnicaמגייס
GSK Investigational SiteWarsawמגייס

United States

מתקןעירמדינה או אזורמצב
GSK Investigational SiteChicagoIllinoisמגייס
GSK Investigational SiteCincinnatiOhioמגייס
GSK Investigational SiteDallasTexasבוטל
GSK Investigational SiteDallasTexasמגייס
GSK Investigational SiteEl DoradoKansasבוטל
GSK Investigational SiteHialeahFloridaמגייס
GSK Investigational SiteHoustonTexasמגייס
GSK Investigational SiteHuntington ParkCaliforniaמגייס
GSK Investigational SiteLafayetteLouisianaמגייס
GSK Investigational SiteLincolnNebraskaמגייס
GSK Investigational SiteMankatoMinnesotaמגייס
GSK Investigational SiteMiamiFloridaמגייס
GSK Investigational SiteNational CityCaliforniaמגייס
GSK Investigational SitePhoenixArizonaבוטל
GSK Investigational SiteRichmondTexasמגייס
GSK Investigational SiteRichmondVirginiaמגייס
GSK Investigational SiteRichmondTexasמגייס
GSK Investigational SiteRoyUtahהושלם
GSK Investigational SiteSan AntonioTexasבוטל
GSK Investigational SiteSyracuseUtahמגייס
GSK Investigational SiteTucsonArizonaבוטל
GSK Investigational SiteViennaVirginiaבוטל
GSK Investigational SiteWest CovinaCaliforniaמגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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