Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
2020年2月17日 更新者：GlaxoSmithKline
Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)
This study will be conducted in two stages.
In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child.
In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC.
No blood samples will be taken in this safety study.
研究概览
地位
完全的
详细说明
Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age.
Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.
研究类型
介入性
注册 (实际的)
798
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。
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
1年 至 1年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ACAC_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
No Mencevax ACWY vaccine at 24 to 30 months of age
|
白喉、破伤风、全细胞百日咳、乙型肝炎、流感嗜血杆菌 b 型脑膜炎球菌 AC-破伤风类毒素结合疫苗
|
|
实验性的：ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
白喉、破伤风、全细胞百日咳、乙型肝炎疫苗、b 型流感嗜血杆菌结合疫苗
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
|
实验性的：HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
白喉、破伤风、全细胞百日咳、乙型肝炎、流感嗜血杆菌 b 型脑膜炎球菌 AC-破伤风类毒素结合疫苗
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
|
实验性的：HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
白喉、破伤风、全细胞百日咳、乙型肝炎疫苗、b 型流感嗜血杆菌结合疫苗
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
|
实验性的：ACAC_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
No Mencevax ACWY vaccine at 24 to 30 months of age
|
白喉、破伤风、全细胞百日咳、乙型肝炎、流感嗜血杆菌 b 型脑膜炎球菌 AC-破伤风类毒素结合疫苗
|
|
实验性的：ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
白喉、破伤风、全细胞百日咳、乙型肝炎疫苗、b 型流感嗜血杆菌结合疫苗
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
|
实验性的：HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
白喉、破伤风、全细胞百日咳、乙型肝炎、流感嗜血杆菌 b 型脑膜炎球菌 AC-破伤风类毒素结合疫苗
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
|
实验性的：HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
|
白喉、破伤风、全细胞百日咳、乙型肝炎疫苗、b 型流感嗜血杆菌结合疫苗
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
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 |
|---|---|---|
|
Number of Subjects With Fever >39°C (Rectal Route).
大体时间：During the 4-day (Day 0-3) follow-up period after booster vaccination
|
Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination.
Grade 3 fever = fever > 39.0 °C.
|
During the 4-day (Day 0-3) follow-up period after booster vaccination
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
大体时间：During the 4-day (Day 0-3) follow-up period after vaccination
|
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 4-day (Day 0-3) follow-up period after vaccination
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
大体时间：During the 4-day (Day 0-3) follow-up period after booster vaccination
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
|
During the 4-day (Day 0-3) follow-up period after booster vaccination
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
大体时间：During the 31-day (Day 0-30) following booster vaccination
|
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
During the 31-day (Day 0-30) following booster vaccination
|
|
Number of Subjects With Serious Adverse Events (SAEs).
大体时间：From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
|
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。
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。
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 (实际的)
2005年6月16日
初级完成 (实际的)
2006年1月20日
研究完成 (实际的)
2006年1月20日
研究注册日期
首次提交
2005年9月27日
首先提交符合 QC 标准的
2005年9月27日
首次发布 (估计)
2005年9月29日
研究记录更新
最后更新发布 (实际的)
2020年2月20日
上次提交的符合 QC 标准的更新
2020年2月17日
最后验证
2020年2月1日
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
- 103812
- 104171 (其他标识符：GSK)
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
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
研究数据/文件
-
统计分析计划
信息标识符：103812信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
个人参与者数据集
信息标识符：103812信息评论：For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103812 are summarised with study 104727 on the GSK Clinical Study Register.
-
知情同意书
信息标识符：103812信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
研究协议
信息标识符：103812信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
数据集规范
信息标识符：103812信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
临床研究报告
信息标识符：103812信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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.