A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live Cold Adapted (CAIV-T) in Healthy Children Aged 6 to Less Than 36 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 4
- 主要终点
- Measurement of influenza-specific immune response following receipt of CAIV-T.
研究概览
简要总结
To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).
• To assess nasal swab specimens to detect vaccine virus shedding.
详细描述
This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10^7 FFU per dose, CAIV-T 10^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children at least 6 months of age 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 judgement;
- •whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
- •who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion);
排除标准
- •whose parents or guardians 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, or cytotoxic agents (see Section 4.2.2);
- •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 study vaccine, placebo or TIV;
- •who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
- •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
Measurement of influenza-specific immune response following receipt of CAIV-T.
时间窗: Day 0 and Day 27
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
次要结局
- Vaccine virus shedding(Days 2, 6, and 13)
- Measurement of influenza-specific immune response following receipt of CAIVT.(Day 0 and Day 27)
- Measurement of influenza-specific immune responses following receipt of CAIVT(Day 0, Day 6, and Day 13)
- Assess the safety and tolerability of CAIV-T vaccine in healthy children.(Day 0-27)