NCT00192257已完成3 期
A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With Asthma Aged 6 Years to 17 Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,229
- 试验地点
- 2
- 主要终点
- To demostrate that the efficacy over one influenza season against culture-confirmed influenza illness caused by community-acquired subtypes antifenically similar to those contained in the vaccine
研究概览
简要总结
- Trial to assess asthma exacerbation through to the end of the study; and to demonstrate that the efficacy over one season against culture-confirmed influenza-illness; and finally to assess the safety and tolerability of CAIV-T in children with asthma.
详细描述
- To assess asthma exacerbation, being defined as acute wheezing illness associated with hospitalization, unscheduled clinic visits, or new prescriptions from study vaccination through to the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who are aged at least 6 years to 17 years of age at the time of enrollment;
- •with a clinical diagnosis of asthma by one of the following criteria:
- •An International Classification of Diseases, Ninth revision (ICD-9) code 493 AND ≥one prescription for asthma medication;
- •OR ≥one prescription for an inhaled beta-agonist and ≥one prescription for cromolyn;
- •OR ≥Five prescriptions for any asthma medication (adapted from Kramarz et al,2000 and Osborne et al., 1995)1,2;
- •asthma medication* is being defined as:
- •inhaled and oral β -agonists
- •theophyllin
- •inhaled, oral and injected steroids
- •other unclassified asthma medication
- •antibiotics used for treatment of respiratory illness associated with a wheezing episode;
- •at least one asthma medication should have been administered in the last 12 months
- •who, if female and is post-menarche, has provided a negative pregnancy test prior to the study vaccination;
- •who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;
- •who, along with their parent(s)/legal guardian(s), will be available for duration of the trial;
- •who/whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
排除标准
- •who/whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- •with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- •with Down's syndrome or other known cytogenetic disorders;
- •with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids of a dose equivalent to a total of 20 mg/day or greater of prednisolone or equivalent, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 25;
- •who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
- •for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
- •who have an immunosuppressed or an immunocompromised individual living in the same household;
- •who received any influenza vaccine in the 6 months prior to enrollment, or are anticipated to receive a non-study influenza vaccine after enrollment;
- •with a documented history of hypersensitivity to egg or egg protein or any other component of the CAIV-T or TIV;
- •who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
- •with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results;
- •Note: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
结局指标
主要结局
To demostrate that the efficacy over one influenza season against culture-confirmed influenza illness caused by community-acquired subtypes antifenically similar to those contained in the vaccine
次要结局
- To demonstrate that the efficacy over one season of a single dose of CAIV-T was not inferior to that of one dose of TIV against culture-confirmed influenza-illness of any subtype
- To compare the efficacy over a defined surveillance period against asthma exacerbations, asthma medication, clinical visits, hospitalizations, days off school (pharma-ecomonic measures) associated with influenza-like illness
研究者
研究点 (2)
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