Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Systemic Reaction
研究概览
简要总结
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
- •Must be in 1st complete remission.
- •Must be 4 weeks into maintenance therapy.
- •17 years of age, inclusive.
- •Available for duration of study.
排除标准
- •History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.
- •History of Guillain-Barre syndrome.
- •Evidence of relapsed disease.
- •Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- •Have any condition that the investigator believes may interfere with successful completion of the study.
- •History of receiving 2010 - 2011 influenza vaccine.
- •Pregnant female.
- •History of proven influenza disease after September 1, 2010.
研究组 & 干预措施
High-Dose trivalent inactivated influenza vaccine
0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
干预措施: High-dose trivalent inactivated influenza vaccine (Drug)
Standard dose trivalent inactivated influenza vaccine
0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
干预措施: Standard dose trivalent inactivated influenza vaccine (Drug)
结局指标
主要结局
Systemic Reaction
时间窗: From baseline to 7 days after each vaccination
Number of participants with systemic reactions after each vaccination
Local Reactions After Each Vaccination
时间窗: From baseline to 7 days after each vaccination
Number of participants with local reactions after each vaccination
次要结局
- Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants(About 6 months after last dose of vaccine.)
- Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise(About 6 months after last dose of vaccine.)
- Immunogenicity:Number of Participants With a Pre-titer ≥1:40(About 6 months after last dose of vaccine.)
- Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants(baseline)
- Immunogenicity: Number of Participants With a Post-titer ≥1:40(About 6 months after last dose of vaccine.)
研究者
Natasha Halasa
Assistant Professor
Vanderbilt University