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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)

2026년 7월 29일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1860

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
생물학적: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
다른 이름들:
  • Kinrix
실험적: 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.
생물학적: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
생물학적: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
다른 이름들:
  • Kinrix
실험적: 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.
생물학적: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
생물학적: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
다른 이름들:
  • Kinrix
활성 비교기: MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
생물학적: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
다른 이름들:
  • Kinrix
생물학적: MMRV vaccine
MMRV vaccine will be administered on Day 1.
다른 이름들:
  • 프로쿼드

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 11일

기본 완료 (추정된)

2028년 6월 27일

연구 완료 (추정된)

2028년 11월 21일

연구 등록 날짜

최초 제출

2026년 7월 29일

QC 기준을 충족하는 최초 제출

2026년 7월 29일

처음 게시됨 (실제)

2026년 8월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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.

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다