NCT04112797Unknown不适用
Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Number of participants with treatment-related adverse events as assessed by WAO classification
研究概览
简要总结
It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom.
- •Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.
- •Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor.
排除标准
- •Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
- •Patients under treatment with immunotherapy against aeroallergens.
- •Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study.
- •Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires.
- •Patients who are participating in another clinical trial or observational study.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by WAO classification
时间窗: During 1 year
All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations.
次要结局
- Efficacy of vaccine evaluating re-sting test(Result of the re-sting test)
研究者
研究点 (8)
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