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Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

2018年7月2日更新者：GlaxoSmithKline

Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

研究概览

地位

完全的

条件

流感

干预/治疗

研究类型

介入性

注册 (实际的)

3317

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。

学习地点

台湾
- - Taipei、台湾、104
    - GSK Investigational Site
  - Taipei、台湾
    - GSK Investigational Site
墨西哥
- - Mexico、墨西哥、6720
    - GSK Investigational Site
  - Mexico city、墨西哥、04530
    - GSK Investigational Site
泰国
- - Bangkok、泰国、10400
    - GSK Investigational Site
美国
- Alabama
  - Birmingham、Alabama、美国、35244
    - GSK Investigational Site
  - Birmingham、Alabama、美国、35205
    - GSK Investigational Site
  - Dothan、Alabama、美国、36305
    - GSK Investigational Site
- Arkansas
  - Benton、Arkansas、美国、72019
    - GSK Investigational Site
  - Conway、Arkansas、美国、72034
    - GSK Investigational Site
  - Fayetteville、Arkansas、美国、72703
    - GSK Investigational Site
  - Jonesboro、Arkansas、美国、72401
    - GSK Investigational Site
  - Little Rock、Arkansas、美国、72205
    - GSK Investigational Site
- California
  - Huntington Beach、California、美国、92647
    - GSK Investigational Site
  - Long Beach、California、美国、90806
    - GSK Investigational Site
  - Paramount、California、美国、90723
    - GSK Investigational Site
  - Sacramento、California、美国、95816
    - GSK Investigational Site
  - San Francisco、California、美国、94102
    - GSK Investigational Site
  - West Covina、California、美国、91790
    - GSK Investigational Site
- Colorado
  - Longmont、Colorado、美国、80501
    - GSK Investigational Site
- Connecticut
  - Norwich、Connecticut、美国、06360
    - GSK Investigational Site
- Idaho
  - Nampa、Idaho、美国、83686
    - GSK Investigational Site
- Illinois
  - DeKalb、Illinois、美国、60115
    - GSK Investigational Site
- Indiana
  - New Albany、Indiana、美国、47150
    - GSK Investigational Site
- Kansas
  - Arkansas City、Kansas、美国、67005
    - GSK Investigational Site
  - Newton、Kansas、美国、67114
    - GSK Investigational Site
  - Wichita、Kansas、美国、67207
    - GSK Investigational Site
- Kentucky
  - Bardstown、Kentucky、美国、40004
    - GSK Investigational Site
  - Louisville、Kentucky、美国、40207
    - GSK Investigational Site
- Louisiana
  - Bossier City、Louisiana、美国、71111
    - GSK Investigational Site
  - Metairie、Louisiana、美国、70006
    - GSK Investigational Site
- Michigan
  - Stevensville、Michigan、美国、49127
    - GSK Investigational Site
- Minnesota
  - Saint Paul、Minnesota、美国、55108
    - GSK Investigational Site
- Missouri
  - Saint Louis、Missouri、美国、63141
    - GSK Investigational Site
- Nebraska
  - Omaha、Nebraska、美国、68134
    - GSK Investigational Site
- Nevada
  - Henderson、Nevada、美国、89015
    - GSK Investigational Site
- New York
  - Cortland、New York、美国、13045
    - GSK Investigational Site
- North Carolina
  - Boone、North Carolina、美国、28607
    - GSK Investigational Site
  - Cary、North Carolina、美国、27518
    - GSK Investigational Site
  - Raleigh、North Carolina、美国、27609
    - GSK Investigational Site
- North Dakota
  - Fargo、North Dakota、美国、58103
    - GSK Investigational Site
- Ohio
  - Austintown、Ohio、美国、44515
    - GSK Investigational Site
  - Cincinnati、Ohio、美国、45245
    - GSK Investigational Site
  - Cleveland、Ohio、美国、44121
    - GSK Investigational Site
  - Dayton、Ohio、美国、45406
    - GSK Investigational Site
- Oregon
  - Gresham、Oregon、美国、97030
    - GSK Investigational Site
- Pennsylvania
  - Erie、Pennsylvania、美国、16505
    - GSK Investigational Site
  - Greenville、Pennsylvania、美国、16125
    - GSK Investigational Site
  - Latrobe、Pennsylvania、美国、15650
    - GSK Investigational Site
  - Pittsburgh、Pennsylvania、美国、15236
    - GSK Investigational Site
  - Uniontown、Pennsylvania、美国、15401
    - GSK Investigational Site
  - Wexford、Pennsylvania、美国、15090
    - GSK Investigational Site
- South Carolina
  - Charleston、South Carolina、美国、29406
    - GSK Investigational Site
- Tennessee
  - Clarksville、Tennessee、美国、37043
    - GSK Investigational Site
  - Jackson、Tennessee、美国、38305
    - GSK Investigational Site
  - Kingsport、Tennessee、美国、37660
    - GSK Investigational Site
- Texas
  - Austin、Texas、美国、78705
    - GSK Investigational Site
  - Fort Worth、Texas、美国、76135
    - GSK Investigational Site
  - Houston、Texas、美国、77055
    - GSK Investigational Site
  - San Angelo、Texas、美国、76904
    - GSK Investigational Site
- Utah
  - Bountiful、Utah、美国、84010
    - GSK Investigational Site
  - Layton、Utah、美国、84041
    - GSK Investigational Site
  - Murray、Utah、美国、84107
    - GSK Investigational Site
  - Provo、Utah、美国、84604
    - GSK Investigational Site
  - Roy、Utah、美国、84067
    - GSK Investigational Site
  - South Jordan、Utah、美国、84095
    - GSK Investigational Site
- Virginia
  - Burke、Virginia、美国、22015
    - GSK Investigational Site
香港
- - Pokfulam、香港
    - GSK Investigational Site
  - Shatin、香港
    - GSK Investigational Site

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

6个月至 2年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

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：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Fluarix Dose A Group Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	生物：Fluarix One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
实验性的：Fluarix Dose B Group Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	生物：Fluarix One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
有源比较器：Fluzone Group Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	生物：Fluzone One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

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 Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains 大体时间：Day 0 (PRE), Day 28 or Day 56 (POST)	GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 0 (PRE), Day 28 or Day 56 (POST)
Number of Subjects Who Seroconverted 大体时间：Day 28 or Day 56	Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 28 or Day 56

次要结果测量

结果测量	措施说明	大体时间
Number of Seroprotected Subjects 大体时间：Day 0 (PRE), Day 28 or Day 56 (POST)	A seroprotected subject is a subject with a serum anti-HA titer ≥ 1:40 Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 0 (PRE), Day 28 or Day 56 (POST)
Seroconversion Factor 大体时间：Day 28 or Day 56	Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0). Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 28 or Day 56
Number of Subjects Reporting Solicited Local Symptoms 大体时间：During a 4-day follow-up period after vaccination	Solicited local symptoms assessed include pain, redness and swelling.	During a 4-day follow-up period after vaccination
Number of Subjects Reporting Solicited General Symptoms 大体时间：During a 4-day follow-up period after vaccination	Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.	During a 4-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE) 大体时间：During a 28-day follow-up period after vaccination	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product	During a 28-day follow-up period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD) 大体时间：During the entire study (Day 0 until Month 6)	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders	During the entire study (Day 0 until Month 6)
Number of Subjects Reporting Rare Serious Events 大体时间：During the entire study (Day 0 until Month 6)	Rare serious events have an occurrence rate of 1/300 (0.3%).	During the entire study (Day 0 until Month 6)

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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

2008年10月1日

初级完成 (实际的)

2009年3月5日

研究完成 (实际的)

2009年6月1日

研究注册日期

首次提交

2008年10月1日

首先提交符合 QC 标准的

2008年10月1日

首次发布 (估计)

2008年10月2日

研究记录更新

最后更新发布 (实际的)

2018年7月31日

上次提交的符合 QC 标准的更新

2018年7月2日

最后验证

2016年10月1日

Fluarix的临床试验

GlaxoSmithKline

完全的

四种候选流感疫苗预防老年人流感的安全性研究

流感

比利时
GlaxoSmithKline

完全的

用于预防老年人流感的佐剂候选流感疫苗的安全性研究

流感

比利时
GlaxoSmithKline

完全的

Fluarix™ / Influsplit SSW® 2008/2009 成人免疫原性和反应原性评估研究

流感

德国
GlaxoSmithKline

完全的

FluarixTM / Influsplit SSW® 2009/2010 成人免疫原性和反应原性评估研究

流感

德国
GlaxoSmithKline

完全的

50 岁及以上接种 Fluarix™ 疫苗的受试者流感及其并发症的发病率研究

流感

美国, 德国, 波兰, 荷兰
Emory University

终止

印记和重复接种流感疫苗对适应性免疫、转录组学和代谢组学的影响 (FLU2)

流感

美国
University of Surrey

完全的

鼻内和肌内疫苗接种后的 T 细胞多样性

流感

英国
GlaxoSmithKline

完全的

Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

流感

比利时
GlaxoSmithKline

完全的

GSK Biologicals 季节性流感疫苗儿童安全性和免疫原性评价研究

流感

西班牙, 台湾, 加拿大, 美国, 墨西哥
GlaxoSmithKline

完全的

GSKs Tdap Vaccine Boostrix 在成人中与 GSKs Influenza Vaccine Fluarix 共同给药时的免疫原性和安全性

破伤风 | 白喉 | 无细胞百日咳

美国

Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

出版物和有用的链接

一般刊物

有用的网址

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

研究数据/文件

Fluarix的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in El Salvador

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点