13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
2015年2月27日 更新者：Pfizer
A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.
It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
500
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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The Gambia
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Ksmd、The Gambia、冈比亚
- Fajikunda Major Health Centre
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The Gambia, West Africa
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Fajara、The Gambia, West Africa、冈比亚、000273
- Medical Research Council Unit, The Gambia
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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个月 至 2个月 (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:
- Aged 42 to 70 days at enrollment.
- Determined by medical history, physical examination, and clinical judgment to be eligible for the study
- Weight of 3.5 kg or greater at the time of enrollment
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Receipt of blood products or gamma-globulin since birth
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：Multidose Vial Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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有源比较器：Single-Dose Syringe Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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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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Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
大体时间：1 month after the infant series
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Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
大体时间：1 month after the infant series
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Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated.
Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
大体时间：Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
大体时间：Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
大体时间：Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
大体时间：Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
大体时间：Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
大体时间：Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
大体时间：Dose 1 up to 28 to 42 days after dose 3
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
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Dose 1 up to 28 to 42 days after dose 3
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
大体时间：Informed consent up to Dose 1
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Adverse events were also reported in participants who provided consent but were not randomized in this study.
The data of these participants has been reported under 'Screened Only' arm.
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Informed consent up to Dose 1
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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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Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
大体时间：1 month after the infant series
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Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
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1 month after the infant series
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Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
大体时间：1 month after the infant series
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Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMTs were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Here "n"= participants evaluable =specified category.
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1 month after the infant series
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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
2014年1月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2013年9月9日
首先提交符合 QC 标准的
2013年10月14日
首次发布 (估计)
2013年10月17日
研究记录更新
最后更新发布 (估计)
2015年3月13日
上次提交的符合 QC 标准的更新
2015年2月27日
最后验证
2015年2月1日
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.