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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)

2026年7月29日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1860

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
生物：MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
生物：DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
其他名称：
  • Kinrix
实验性的：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.
生物：MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
生物：DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
其他名称：
  • Kinrix
实验性的：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.
生物：MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
生物：DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
其他名称：
  • Kinrix
有源比较器：MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
生物：DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
其他名称：
  • Kinrix
生物：MMRV vaccine
MMRV vaccine will be administered on Day 1.
其他名称：
  • ProQuad

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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
大体时间：At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月11日

初级完成 (估计的)

2028年6月27日

研究完成 (估计的)

2028年11月21日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 217717
  • 2025-523277-42-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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