Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
2011年9月29日 更新者:Sanofi
This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
- To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
研究概览
详细说明
Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level.
All participants will be monitored for safety for 30 days after each injection.
研究类型
介入性
注册 (实际的)
63
阶段
- 阶段1
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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Allschwil、瑞士
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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
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Aged 18 to 50 years on the day of inclusion
- Healthy, as determined by medical history and clinical examination
- Informed consent obtained
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
- For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination.
Exclusion Criteria:
- Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
- For a woman, breast-feeding
- Participation in another clinical trial in the 30 days preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Blood or blood-derived products received in the past 3 months
- Any vaccination in the 30 days preceding the first trial vaccination
- Vaccination planned in the 30 days following any trial vaccination
- Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
- Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (≥ 38.0°C [or 100.4°F]) within 72 hours of inclusion/vaccination
- Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine
- History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
- Subject at high risk of pneumococcal infection during the trial
- Subjects living in a household with children < 5 years of age
- Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).
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:Pneumococcal Vaccine Dose 1 (Low dose)
Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.
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0.5 mL, intramuscular
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实验性的:Pneumococcal Vaccine Dose 2 (Middle dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.
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0.5 mL, intramuscular
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实验性的:Pneumococcal Vaccine Dose 3 (High dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.
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0.5 mL, intramuscular
|
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 |
|---|---|---|
|
The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
大体时间:Day 0 up to Day 60 post vaccination
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Solicited injection site reactions: Pain, Erythema, and Swelling.
Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
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Day 0 up to Day 60 post 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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Immunogenicity of pneumococcal vaccine after 2 vaccinations
大体时间:Day 0 and 30 days post vaccination
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Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).
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Day 0 and 30 days post vaccination
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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
调查人员
- 研究主任:Medical Director、Sanofi Pasteur Ltd.
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
2007年2月1日
初级完成 (实际的)
2007年8月1日
研究完成 (实际的)
2007年8月1日
研究注册日期
首次提交
2011年9月28日
首先提交符合 QC 标准的
2011年9月29日
首次发布 (估计)
2011年9月30日
研究记录更新
最后更新发布 (估计)
2011年9月30日
上次提交的符合 QC 标准的更新
2011年9月29日
最后验证
2011年9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.