PACTR201403000646306已完成2 期
A phase II, randomized, observer-blinded, single centre trial evaluating the immunogenicity and safety of 2 doses of an adjuvated TB subunit vaccine (Ag85B-ESAT-6 + IC31®) using 2 different vaccination schedules in healthy adolescents
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
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
- 年龄范围
- 12 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •1. Male or female
- •2. Healthy based on medical examination/history at the inclusion
- •3. Age 12-18 years (inclusive)
- •4. Signed informed consent
- •5. Signed informed assent
- •6. Prepared to grant authorized persons access to the medical records
- •7. If of childbearing potential, she must have abstained from sex or used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for the duration of the trial.
- •8. The volunteer is likely to comply with instructions
排除标准
- •1. Confirmed current or prior active TB disease based on clinical evaluation (history, physical findings and investigations)
- •2. Vaccinated with any vaccine 3 months before first vaccination
- •3. Administration of immune modulating drugs (oral steroids, immunosuppressive drugs or immunoglobulins) (inhaled and topical steroids excluded)
- •4. HIV sero-positive or unwilling to be tested for HIV
- •5. Participation in other clinical trials involving an experimental investigational product.
- •6. Known hypersensitivity to any of the vaccine components
- •7. Laboratory parameters outside of normal range considered clinically relevant in the opinion of the investigator.
- •8. Female participants who will most likely fail to abstain or to use adequate contraceptive precautions for 30 days prior to vaccination, and those who will most likely fail to agree to continue adequate contraceptive precautions for the duration of the trial
- •9. Positive pregnancy test
- •10. Breast feeding females
研究者
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