EUCTR2023-000924-13-Outside-EU/EEA进行中（未招募）1 期
A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity study to assess Pentavalent Meningococcal ABCYW Vaccine formulations in Adults (18 to 25 years of age) and Adolescents (10 to 17 years of age).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Aged 18 to 25 years or 10 to 17 years on the day of inclusion
- •- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.
- •- Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Known or suspected congenital or acquired immunodeficiency
- •- History of any Neisseria meningitidis infection
- •- At high risk for meningococcal infection during the study
- •- Individuals with active tuberculosis
- •- History of Guillain-Barré syndrome
- •- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
- •NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究者
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