Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 9
- 主要终点
- Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers
研究概览
简要总结
This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether high-dose trivalent inactivated influenza vaccine (HD-TIV) compared with standard dose quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination-inhibition (HAI) titers, >= 1:40 HAI titer, or higher geometric mean titer (GMT) to influenza A antigens in pediatric hematopoietic stem cell transplant (HSCT) recipients.
SECONDARY OBJECTIVES:
I. To determine whether HD-TIV compared with standard dose QIV will increase the probability of achieving a >= 4-fold rise in HAI titers, >= 1:40 HAI titer, or higher GMT titers to influenza B antigens in pediatric HSCT recipients.
II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/ tenderness, redness, and swelling at injection site) with HD-TIV compared to standard QIV in pediatric HSCT recipients.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 - High Dose TIV
Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.
干预措施: Trivalent Influenza Vaccine (Biological)
Group 1 - High Dose TIV
Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.
干预措施: Laboratory Biomarker Analysis (Other)
Group 2 - Standard Dose QIV
Patients receive standard dose QIV IM on day 0 and day 28.
干预措施: Quadrivalent Influenza Vaccine (Biological)
Group 2 - Standard Dose QIV
Patients receive standard dose QIV IM on day 0 and day 28.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers
时间窗: Visit 1 (baseline) was day 0; visit 2 was 28-42 days after visit 1; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2.
Point estimates and 95% confidence intervals for proportion of subjects achieving seroconversion (4-fold or greater rise in HAI titers from visit 1).
次要结局
- Proportion of Solicited Local and Systemic Adverse Events(Up to 7 days following each vaccination: up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2)
- T and B Cell Phenotype Assessed by Mass Cytometry(Visit 1 (baseline) was day 0; visit 2 was 28-42 days after visit 1; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2.)
- T and B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays(Visit 1 (baseline) was day 0; optional visit 1 was 5-10 days after visit 1; visit 2 was 28-42 days after visit 1; optional visit 2 was 5-10 days after visit 2; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2.)
- Percentage of Individuals in Each Group Who Test Positive for Influenza(During the influenza season, up to 6 months)
研究者
Natasha Halasa, MD
Professor of Pediatrics
Vanderbilt-Ingram Cancer Center