NCT05480462进行中（未招募）3 期
Single Blind, Randomized, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Booster Immunization With Bivalent Vaccine Against Tetanus and Diphtheria CLODIVAC (IBSS Biomed S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in Healthy Adults.
IBSS Biomed S.A.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Seroconversion
研究概览
简要总结
A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Approved informed consent.
- •Men and women aged 18- 65 years.
- •Written confirmation on previous immunization against diphtheria and tetanus not older than 16 years and not younger than 4 years.
排除标准
- •Subject with acute infectious diseases.
- •Subject allergic to any of the substances of the IMP administered in clinical trial.
- •Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus or diphtheria.
- •Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, drugs or other causes induced immunodeficiency).
- •Subject with progressive or unstable neurological disorder.
- •Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular administration.
- •Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
- •Subject vaccinated less than 14 days inactivated or live vaccine prior to study entry.
- •Pregnant woman and breastfeeding (anamnestically).
- •Subject incapable of cooperation.
- •Alcohol or drug abuse.
- •Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
- •Subjects requiring vaccination against tetanus after severe injury.
- •Any other condition that in the Investigator's opinion may affect the safety of the test participant or the integrity of data obtained during the study.
结局指标
主要结局
Seroconversion
时间窗: 28 days
The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.
次要结局
- The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.(28 days)
研究者
研究点 (2)
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