NCT00192413已完成3 期
A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,009
- 试验地点
- 4
- 主要终点
- The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine.
研究概览
简要总结
To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •who are aged at least 60 years or older at the time of enrollment;
- •who are determined by medical history, physical examination and clinical judgement to be eligible for this study;
- •who have provided written informed consent after the nature of the study has been explained;
- •who will be available for duration of the trial (from enrollment to November 30th, 2003);
- •who can be reached by study staff for the post-vaccination and weekly surveillance contacts [telephone, clinic or home visit].
排除标准
- •who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- •who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to Influenza study specific manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial;
- •with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (Subjects with other stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible).
- •with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to Influenza study specific manual);
- •with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
- •who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
- •have an immunosuppressed or an immunocompromised individual living in the same household;
- •with a documented history of hypersensitivity to egg or egg protein or any other component of the CAIV-T or TIV vaccine;
- •who were administered any live virus vaccine within one month prior to vaccination or expected to receive another live virus vaccine within one month of vaccination in this 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 received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
- •who receive any influenza vaccine in the 6 months prior to enrollment, or intend to receive a non-study influenza vaccine after enrollment;
- •with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment.
结局指标
主要结局
The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine.
时间窗: Dosing through 30Nov2002
The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.
次要结局
- The first episode of a culture-confirmed influenza-illness, caused by any community-acquired subtype, which occurs at least 15 days following receipt of a dose of study vaccine.(15 days after dosing through 30Nov2002)
- The first episode in a study subject of a culture-confirmed influenza illness caused by community-acquired virus of each of the subtypes antigenically similar to those contained in the vaccine(15 days after dosing through 30Nov2002)
- The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes.(15 days after dosing through 30Nov2002)
- The first episode of influenza-like illness(15 days after dosing through 30Nov2002)
- Incidence of clinic visits(15 days after dosing through 30Nov2002)
- Incidence of hospitalization(15 days after dosing through 30Nov2002)
- Incidence of confirmed pneumonia(15 days after dosing through 30Nov2002)
- Incidence of death due to influenza-like illness(15 days after dosing through 30Nov2002)
- Incidence of seroconversion(Day 0-35)
- Incidence of systemic reactogenicity events(Day 0-10)
- Incidence of local reactions(Days 0-10)
- Incidence of adverse events(Days 0-10)
研究者
研究点 (4)
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