Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
2011年10月5日 更新者：Pfizer
A Phase 3, Open-Label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13vPnC When Administered to Healthy Japanese Adults Aged >= 65 Years and 50 to 64 Years in Japan Who Have Not Received a Previous Dose of 23-Valent Pneumococcal Polysaccharide Vaccine
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50 years.
研究概览
研究类型
介入性
注册 (实际的)
271
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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Fukuoka
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Fukuoka-shi、Fukuoka、日本、812-0025
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Tokyo
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Sumida-ku、Tokyo、日本、130-0004
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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
50年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Japanese descent male and female adults who do not have the potential to bear children >= 50 years of age.
- Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
- Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine.
- Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
- Documented S pneumoniae infection within the past 5 years before study vaccination.
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：非随机化
- 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：1
Stratum 1: >= 65 years of age
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13vPnC for both stratum
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实验性的：2
Stratum 2: 50 to 64 years of age
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13vPnC for both stratum
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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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Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
大体时间：1 month after vaccination
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Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA).
OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
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1 month after vaccination
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Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：1 month after vaccination
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Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA).
OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
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1 month after vaccination
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Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population
大体时间：Prevaccination (Day 1), 1 month after vaccination
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Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results.
CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
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Prevaccination (Day 1), 1 month after vaccination
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Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：Prevaccination (Day 1), 1 month after vaccination
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Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results.
CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
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Prevaccination (Day 1), 1 month after 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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Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group
大体时间：1 month after vaccination
|
Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA).
OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
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1 month after vaccination
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Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population
大体时间：1 month after vaccination
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For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：1 month after vaccination
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For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group
大体时间：1 month after vaccination
|
For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population
大体时间：1 month after vaccination
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For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：1 month after vaccination
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For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group
大体时间：1 month after vaccination
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For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population
大体时间：1 month after vaccination
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For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：1 month after vaccination
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For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group
大体时间：1 month after vaccination
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For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
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1 month after vaccination
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Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
大体时间：1 month after vaccination
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Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA).
IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL).
The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
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1 month after vaccination
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Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：1 month after vaccination
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Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA).
IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL).
The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
|
1 month after vaccination
|
|
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group
大体时间：1 month after vaccination
|
Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA).
IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL).
The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
|
1 month after vaccination
|
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Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
大体时间：1 month after vaccination
|
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results.
CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
|
1 month after vaccination
|
|
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：1 month after vaccination
|
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results.
CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
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1 month after vaccination
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population
大体时间：Day 1 through 14
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Local reactions reported using electronic diary.
Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm).
Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity).
Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).
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Day 1 through 14
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：Day 1 through 14
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Local reactions reported using electronic diary.
Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm).
Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity).
Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).
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Day 1 through 14
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population
大体时间：Day 1 through 14
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Systemic events reported using electronic diary.
Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C).
Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.
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Day 1 through 14
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
大体时间：Day 1 through 14
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Systemic events reported using electronic diary.
Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C).
Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.
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Day 1 through 14
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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。
赞助
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
2007年10月1日
初级完成 (实际的)
2007年12月1日
研究完成 (实际的)
2007年12月1日
研究注册日期
首次提交
2007年11月20日
首先提交符合 QC 标准的
2007年11月21日
首次发布 (估计)
2007年11月22日
研究记录更新
最后更新发布 (估计)
2011年11月11日
上次提交的符合 QC 标准的更新
2011年10月5日
最后验证
2011年10月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 6115A1-3004
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.
13vPnC的临床试验
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Pfizer完全的疫苗，肺炎球菌结合疫苗美国, 西班牙, 法国, 加拿大, 德国, 捷克语, 瑞典, 比利时, 波兰, 荷兰