NCT00192244已完成3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- The primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes.
研究概览
简要总结
- The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •who are greater than or equal to 6 months and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- •whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
- •who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
- •whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].
排除标准
- •whose parents or caregiver are perceived to be unreliable 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;
- •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;
- •with an immunosuppressed or compromised 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);
- •who were administered any live virus vaccine within one month prior to study vaccination or expected receipt of another live virus within one month of vaccination in this study;
- •with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
- •with a respiratory illness with wheezing within two weeks prior to enrollment;
- •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: A pregnant household member or day care provider is not considered a contraindication to enrollment.
结局指标
主要结局
The primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes.
次要结局
- The secondary endpoint for efficacy is the first episode during the second year in a study child of a culture-confirmed influenza-illness.
研究者
研究点 (1)
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