Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
2016年1月4日 更新者：Sanofi Pasteur, a Sanofi Company
Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
Study Objective:
- To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.
Observational Objectives:
- To describe the long-term antibody persistence by group and by stratification on the age at inclusion of the A3L27 booster study.
- To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4 vs 5 doses of poliovirus administered).
研究概览
地位
完全的
详细说明
No investigational vaccine will be administered in the study. Subjects who were previously randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be invited to take part in this study.
Any serious adverse events (SAEs) related to the vaccines administered during the preceding trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the trial.
No vaccine will be administered as part of this study.
研究类型
介入性
注册 (实际的)
558
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。
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
3年 至 4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:
- Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar [PCV7] and Rotarix) and a booster dose during the trial A3L27 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar [PCV7]).
Exclusion Criteria:
- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Incomplete primary and booster immunization at trial A3L24 and A3L27
- Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection(s), confirmed either clinically, serologically, or microbiologically after completion of trial A3L27
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood drawn
- Acute or chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
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 |
|---|---|
|
实验性的：Study Group 1
Participants who received 3 doses of DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study.
|
DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study
|
|
实验性的：Study Group 2
Participants who received 3 doses of DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of Infanrix hexa vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study.
|
DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study.
|
|
有源比较器：Study Group 3
Participants who received 3 doses of Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study.
|
Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study.
|
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 |
|---|---|---|
|
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine
大体时间：Up to 60 days following enrollment
|
Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥ 1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) antibody concentrations Lower Limit of Quantitation (LLOQ), ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)
|
Up to 60 days following enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine
大体时间：Up to 12 months following enrollment
|
Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) Ab concentrations LLOQ, ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)
|
Up to 12 months following enrollment
|
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。
有用的网址
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
2013年10月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2013年11月7日
首先提交符合 QC 标准的
2013年11月7日
首次发布 (估计)
2013年11月14日
研究记录更新
最后更新发布 (估计)
2016年1月5日
上次提交的符合 QC 标准的更新
2016年1月4日
最后验证
2016年1月1日
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
- A3L28
- U1111-1122-2457 (其他标识符：WHO)
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.