Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
研究概览
地位
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
-
-
-
Kolkata、印度、700073
- GSK Investigational Site
-
Ludhiana、印度、141 008
- GSK Investigational Site
-
Pune、印度
- GSK Investigational Site
-
Vellore、印度、632004
- GSK Investigational Site
-
-
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:
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Babies for which birth weight is < 2 kilogram.
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
|
肌肉注射,3剂
Intramuscular injection, 3 doses
其他名称:
|
有源比较器:Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
|
Intramuscular injection, 3 doses
其他名称:
Intramuscular injection, 3 doses
其他名称:
|
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 |
---|---|---|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
大体时间:One month after primary immunization (month 3)
|
Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after primary immunization (month 3)
|
Concentration of Antibody Against Protein D (PD)
大体时间:One month after primary immunization (month 3)
|
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
|
One month after primary immunization (month 3)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
大体时间:One month after primary immunization (month 3)
|
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8. |
One month after primary immunization (month 3)
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
大体时间:One month after primary immunization
|
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. The cut-off was defined as 0.20 microgram per milliliter (µg/mL). |
One month after primary immunization
|
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
大体时间:One month after primary immunization (month 3)
|
Concentrations were expressed as GMCs in µg/mL.
Pneumococcal cross-reactive serotypes included 6A and 19A.
|
One month after primary immunization (month 3)
|
Number of Subjects Seropositive for Pneumococcal Serotypes
大体时间:One month after primary immunization (month 3)
|
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL |
One month after primary immunization (month 3)
|
Number of Subjects Seropositive for Protein D (PD)
大体时间:One month after primary immunization (month 3)
|
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
|
One month after primary immunization (month 3)
|
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
大体时间:One month after primary immunization (month 3)
|
Concentration is expressed as GMC in µg/mL.
|
One month after primary immunization (month 3)
|
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
大体时间:One month after primary immunization (month 3)
|
Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
|
One month after primary immunization (month 3)
|
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
大体时间:One month after primary immunization (month 3)
|
Concentration was expressed as GMC in EL.U/mL.
|
One month after primary immunization (month 3)
|
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
大体时间:One month after primary immunization (month 3)
|
Concentration was expressed as GMC in milli international units per milliliter (mIU/mL).
As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
|
One month after primary immunization (month 3)
|
Number of Subjects Seropostive for B. Pertussis
大体时间:One month after primary immunization (month 3)
|
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
|
One month after primary immunization (month 3)
|
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
大体时间:One month after primary immunization (month 3)
|
Seroprotection was defined as: Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL. |
One month after primary immunization (month 3)
|
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
大体时间:One month after primary immunization (month 3)
|
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
|
One month after primary immunization (month 3)
|
Number of Subjects With Solicited Local and General Symptoms
大体时间:Within 4 days (day 0-3) after vaccination
|
Solicited local symptoms included pain, redness and swelling.
Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
|
Within 4 days (day 0-3) after vaccination
|
Number of Subjects With Unsolicited Adverse Events (AEs)
大体时间:Within 31 days (day 0-30) after vaccination
|
An AE is 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. Unsolicited AE covers any AE 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 |
Within 31 days (day 0-30) after vaccination
|
Number of Subjects With Serious Adverse Events (SAEs)
大体时间:Following first vaccination (Month 0) throughout the entire study period (month 3)
|
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.
|
Following first vaccination (Month 0) throughout the entire study period (month 3)
|
合作者和调查者
出版物和有用的链接
一般刊物
- Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.
- Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 111188
- 2011-004644-22 (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)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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
-
研究协议
信息标识符:111188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:111188信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
带注释的病例报告表
信息标识符:111188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:111188信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符:111188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:111188信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
统计分析计划
信息标识符:111188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.