Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
2019年11月15日 更新者：GlaxoSmithKline
Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究概览
地位
完全的
条件
详细说明
Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.
For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.
研究类型
介入性
注册 (实际的)
1000
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
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Espoo、芬兰、02100
- GSK Investigational Site
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Helsinki、芬兰、00100
- GSK Investigational Site
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Helsinki、芬兰、00930
- GSK Investigational Site
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Jarvenpaa、芬兰、04400
- GSK Investigational Site
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Kotka、芬兰、48600
- GSK Investigational Site
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Kuopio、芬兰、70100
- GSK Investigational Site
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Lahti、芬兰、15140
- GSK Investigational Site
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Oulu、芬兰、90100
- GSK Investigational Site
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Pori、芬兰、28100
- GSK Investigational Site
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Seinajoki、芬兰、60100
- GSK Investigational Site
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Tampere、芬兰、33100
- GSK Investigational Site
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Turku、芬兰、20520
- GSK Investigational Site
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Vantaa、芬兰、01300
- GSK Investigational Site
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Vantaa、芬兰、01600
- GSK Investigational Site
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age at the time of the vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
- Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- History of meningococcal disease.
- Previous vaccination against measles, mumps, rubella, and/or varicella.
- History of measles, mumps, rubella and/or varicella.
- Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three 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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nimenrix + Priorix-Tetra Group
Subjects received 1 dose of Nimenrix vaccine and 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.
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Single dose intramuscular injection
2-dose subcutaneous injection
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实验性的：Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.
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Single dose intramuscular injection
2-dose subcutaneous injection
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有源比较器：Priorix-Tetra Group
Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.
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2-dose subcutaneous injection
Single dose intramuscular injection
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有源比较器：Meningitec Group
Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.
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2-dose subcutaneous injection
Single dose intramuscular injection
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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 |
|---|---|---|
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Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values
大体时间：42 days after the first vaccine dose (Day 42)
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The cut-off values for the rSBA titers were ≥ 1:8.
The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
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42 days after the first vaccine dose (Day 42)
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Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values
大体时间：42 days after the first vaccine dose (Day 42)
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The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).
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42 days after the first vaccine dose (Day 42)
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Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
大体时间：42 days after the first vaccine dose (Day 42)
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The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).
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42 days after the first vaccine dose (Day 42)
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Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.
大体时间：42 days after the first vaccine dose (Day 42)
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The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).
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42 days after the first vaccine dose (Day 42)
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Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values
大体时间：42 days after the first vaccine dose (Day 42)
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The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.
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42 days after the first vaccine dose (Day 42)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
大体时间：Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
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The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.
At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA.
For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
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Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
大体时间：Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
|
Antibody titers were expressed as geometric mean titers (GMTs).
At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA.
For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
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Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
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Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
大体时间：Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
|
Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL).
At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
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Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
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Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
大体时间：Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
|
The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively.
At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
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Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
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Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
大体时间：Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
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The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively.
The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
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Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
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hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
大体时间：Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
|
Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively.
The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
|
Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
|
|
Anti-measles Antibody Concentrations
大体时间：42 days after the first vaccine dose (Day 42)
|
Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.
|
42 days after the first vaccine dose (Day 42)
|
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Anti-measles Antibody Concentrations
大体时间：42 days after the second Priorix-Tetra vaccine dose (Day 126)
|
Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
|
42 days after the second Priorix-Tetra vaccine dose (Day 126)
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Anti-mumps Antibody Concentrations
大体时间：42 days after the first vaccine dose (Day 42)
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Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.
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42 days after the first vaccine dose (Day 42)
|
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Anti-mumps Antibody Concentrations
大体时间：42 days after the second Priorix-Tetra vaccine dose (Day 126)
|
Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.
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42 days after the second Priorix-Tetra vaccine dose (Day 126)
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Anti-rubella Antibody Concentrations
大体时间：42 days after the first vaccine dose (Day 42)
|
Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.
|
42 days after the first vaccine dose (Day 42)
|
|
Anti-rubella Antibody Concentrations
大体时间：42 days after the second Priorix-Tetra vaccine dose (Day 126)
|
Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
|
42 days after the second Priorix-Tetra vaccine dose (Day 126)
|
|
Anti-varicella Antibody Titers
大体时间：42 days after the first vaccine dose (Day 42)
|
Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.
|
42 days after the first vaccine dose (Day 42)
|
|
Anti-varicella Antibody Titers
大体时间：42 days after the second Priorix-Tetra vaccine dose (Day 126)
|
Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.
|
42 days after the second Priorix-Tetra vaccine dose (Day 126)
|
|
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination
大体时间：During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
|
Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively.
The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
|
During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
|
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Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0
大体时间：During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
|
Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively.
The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.
|
During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
|
|
Number of Subjects Reporting Solicited General Symptoms
大体时间：During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
|
Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.
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During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
|
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Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms
大体时间：During the 43-day (Days 0-42) after first vaccination dose
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Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.
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During the 43-day (Days 0-42) after first vaccination dose
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Number of Subjects Reporting Specific Adverse Events (AEs)
大体时间：From Day 0 up to Month 6 after first vaccine dose
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Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.
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From Day 0 up to Month 6 after first vaccine dose
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Number of Subjects Reporting Unsolicited Symptoms
大体时间：During the 43-day (Days 0-42) post Dose 1 vaccination period
|
Unsolicited symptom covers any symptom 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.
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During the 43-day (Days 0-42) post Dose 1 vaccination period
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Number of Subjects Reporting Unsolicited Symptoms
大体时间：During the 43-day (Days 0-42) follow-up period after each vaccination
|
Unsolicited symptom covers any symptom 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.
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During the 43-day (Days 0-42) follow-up period after each vaccination
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Number of Subjects Reporting Serious Adverse Events (SAEs)
大体时间：From Day 0 up to Month 6 after vaccination
|
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
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From Day 0 up to Month 6 after vaccination
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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。
一般刊物
- Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.
- Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial. Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.
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)
2007年6月5日
初级完成 (实际的)
2008年2月26日
研究完成 (实际的)
2008年3月26日
研究注册日期
首次提交
2007年5月15日
首先提交符合 QC 标准的
2007年5月15日
首次发布 (估计)
2007年5月16日
研究记录更新
最后更新发布 (实际的)
2019年11月18日
上次提交的符合 QC 标准的更新
2019年11月15日
最后验证
2019年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 109670
- 2006-006580-23 (EudraCT编号)
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.
IPD 共享时间框架
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD 共享访问标准
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 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
研究数据/文件
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带注释的病例报告表
信息标识符：109670信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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知情同意书
信息标识符：109670信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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统计分析计划
信息标识符：109670信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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研究协议
信息标识符：109670信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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临床研究报告
信息标识符：109670信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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个人参与者数据集
信息标识符：109670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：109670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.
Meningococcal vaccine GSK134612 (Nimenrix)的临床试验
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GlaxoSmithKline完全的感染，脑膜炎球菌泰国, 爱沙尼亚, 多明尼加共和国