Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Mexico City、墨西哥、06760
- GSK Investigational Site
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Mexico City、墨西哥、04530
- GSK Investigational Site
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Mexico City、墨西哥、06400
- GSK Investigational Site
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Morelia、墨西哥、58070
- GSK Investigational Site
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Buenos Aires、阿根廷、C1425EFD
- GSK Investigational Site
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Buenos Aires、阿根廷、C1425DEM
- GSK Investigational Site
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Cordoba、阿根廷、X5000JRD
- GSK Investigational Site
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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
Inclusion Criteria:
- Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
- Available for all the visits scheduled in the study.
- In good health as determined by medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
- History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
- Previous known or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
- History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
- Immune deficiency disorder, or known HIV infection.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
- History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
- History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
- Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
- Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
- Family members or household members of site research staff.
- Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
- History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
学习计划
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：rMenB+ACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
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4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
其他名称：
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
其他名称：
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有源比较器：rMENB
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
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4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
其他名称：
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有源比较器：MenACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
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4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
其他名称：
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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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Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
大体时间：At Day 331 (one month after the fourth vaccination)
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Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 331 (one month after the fourth vaccination)
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hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 331 (one month after the fourth vaccination)
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hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
At Day 331 (one month after the fourth vaccination)
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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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hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
大体时间：At Day 1
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hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
At Day 1
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hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
大体时间：At Day 151 (one month after the third vaccination)
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hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
At Day 151 (one month after the third vaccination)
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hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
大体时间：At Day 301 (before the fourth vaccination)
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hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
At Day 301 (before the fourth vaccination)
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hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
大体时间：At Day 331 (one month after the fourth vaccination)
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hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
At Day 331 (one month after the fourth vaccination)
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hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
大体时间：At Day 1
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hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
At Day 1
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hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 151 (one month after the third vaccination)
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hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
At Day 151 (one month after the third vaccination)
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hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
大体时间：At Day 301 (before the fourth vaccination)
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hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
At Day 301 (before the fourth vaccination)
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hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
大体时间：At Day 331 (one month after the fourth vaccination)
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hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
At Day 331 (one month after the fourth vaccination)
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Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
大体时间：At Day 1
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Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
At Day 1
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Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
大体时间：At Day 151 (one month after the third vaccination)
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Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 151 (one month after the third vaccination)
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Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
大体时间：At Day 301 (before the fourth vaccination)
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Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 301 (before the fourth vaccination)
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Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
大体时间：At Day 331 (One month after the fourth vaccination)
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Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 331 (One month after the fourth vaccination)
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Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
大体时间：At Day 1
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Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 1
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Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
大体时间：At Day 151 (one month after the third vaccination)
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Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 151 (one month after the third vaccination)
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Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
大体时间：At Day 301 (before the fourth vaccination)
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Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 301 (before the fourth vaccination)
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Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains
大体时间：At Day 331 (one month after the fourth vaccination)
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Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
At Day 331 (one month after the fourth vaccination)
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Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 1
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Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
At Day 1
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Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 151 (one month after the third vaccination)
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Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
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At Day 151 (one month after the third vaccination)
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Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 301 (before the fourth vaccination)
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Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
At Day 301 (before the fourth vaccination)
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Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 331 (one month after the fourth vaccination)
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Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
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At Day 331 (one month after the fourth vaccination)
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Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains
大体时间：At Day 331 (one month after fourth vaccination)
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Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).
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At Day 331 (one month after fourth vaccination)
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Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y
大体时间：At Day 331 (one month after the fourth vaccination)
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Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).
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At Day 331 (one month after the fourth vaccination)
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Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains
大体时间：At Day 331 (one month after the fourth vaccination)
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Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301). This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups. For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2). |
At Day 331 (one month after the fourth vaccination)
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Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 331 (one month after the fourth vaccination)
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Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4). |
At Day 331 (one month after the fourth vaccination)
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Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 1
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Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
At Day 1
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Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 151 (one month before the third vaccination)
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Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
At Day 151 (one month before the third vaccination)
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Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 301 (before the fourth vaccination)
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Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
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At Day 301 (before the fourth vaccination)
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Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
大体时间：At Day 331 (one month after the fourth vaccination)
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Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
At Day 331 (one month after the fourth vaccination)
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Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
大体时间：From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
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Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination
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From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
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Number of Subjects With Unsolicited Adverse Events
大体时间：From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
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An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
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From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
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Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)
大体时间：Throughout the whole study period (from Day 1 upto Day 331)
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A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.
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Throughout the whole study period (from Day 1 upto Day 331)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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
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 group B Vaccine, rMenB+OMV NZ的临床试验
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Novartis Vaccines完全的
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Novartis VaccinesGlaxoSmithKline完全的脑膜炎球菌病 | 流行性脑膜炎比利时, 捷克语, 德国, 意大利, 西班牙, 英国