High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
研究概览
简要总结
This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination inhibition assay (HAI) titer, >= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients.
SECONDARY OBJECTIVES:
I. To determine whether HD-TIV compared with SD-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 adult 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 SD-QIV in adult 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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 I (HD-TIV)
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (HD-TIV)
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
干预措施: Trivalent Influenza Vaccine (Biological)
Group 2(SD-QIV)
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
干预措施: Quadrivalent Inactivated Influenza Vaccine (Biological)
Group 2(SD-QIV)
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
时间窗: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.
次要结局
- Solicited Systemic Adverse Events(Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.)
- Percentage of Individuals in Each Group That Test Positive for Influenza by PCR(Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.)
- HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity(Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.)
- Solicited Local Injection Site Adverse Events(Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.)
研究者
Natasha Halasa, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center