Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Rate of Seroprotection After 1 Dose of Vaccine
研究概览
简要总结
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
详细描述
The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV.
The secondary objectives of this study are to:
- Describe the safety and reactogenicity of high-dose and standard-dose TIV.
- Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV.
- Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
- •Written informed consent (and assent, if applicable) obtained.
- •Participant has a diagnosis of cancer or HIV.
- •If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
- •Exclusion Criteria
- •Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
- •History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
- •Not willing to agree to acceptable birth control for three months after study immunization
排除标准
- 未提供
结局指标
主要结局
Rate of Seroprotection After 1 Dose of Vaccine
时间窗: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
时间窗: 21 to 42 days after second dose
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Rate of Seroconversion After 1 Dose of Vaccine
时间窗: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was \<10, or a 4-fold rise in HAI titer if the baseline ≥10.
次要结局
- Number of Systemic Reactogenicity Events After First Dose(First 14 days after vaccination)
- Comparison of Geometric Mean Titer (GMT) by HAI(Pre-vaccination, post-vaccination and 9 months after vaccination)
- Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)(ALC at baseline and vaccine response at least 21 days after last dose of vaccine)
- Number of Local Reactogenicity Events After First Dose(First 14 days after vaccination)
- Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD(From initial vaccine administration through up to 8 months)
- Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD(at least 21 days after each dose of vaccine)
- Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)(ALC at baseline and vaccine response at least 21 days after last dose of vaccine)
- Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD(at least 21 days after each dose of vaccine)
- Number of Local Reactogenicity Events After Second Dose(First 14 days after vaccination)
- Number of Systemic Reactogenicity Events After Second Dose(First 14 days after vaccination)
- Comparison of Geometric Mean Ratios (GMR) by HAI(Pre-vaccination, post-vaccination and 9 months after vaccination)