NCT00192205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 a History of Recurrent Respiratory Tract Infections Aged 6 Months to Less Than 72 Months
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 4
- 主要终点
- To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
研究概览
简要总结
- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.
详细描述
- The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age.
- The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.
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 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who are aged at least 6 months and less than 72 months of age at the time of enrolment;
- •who have experienced two or more practitioner attended RTIs* in the past 12 months (since birth if less than 12 months old); * RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia.
- •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;
- •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
- •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 (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27;
- •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 enrolment through to the conclusion of the study;
- •who have an immunosuppressed or an immunocompromised individual living in the same household;
- •who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) or is 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 CAIV-T or TIV;
- •who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment 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 enrolment or ongoing participation of the subject in the study.
结局指标
主要结局
To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
次要结局
- To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype
- To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
- To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs
研究者
研究点 (4)
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