Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 4
- 主要终点
- Number of Participants With Seroconversion Response In 2019
研究概览
简要总结
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).
详细描述
This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 28 (range 21-35 days). The primary objective of the study is to determine pre- and post-serologic responses to each vaccine type.
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
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 4-21 years;
- •has prior vaccination history available (which can be determined based either on medical record review or through state registry review);
- •plans to receive the current seasonal influenza vaccination at one of the recruiting sites
排除标准
- •unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
- •has already received influenza vaccine for the current season;
- •has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days);
- •is known to be pregnant;
- •has a history of severe allergy to eggs or to influenza vaccine or any of its components
结局指标
主要结局
Number of Participants With Seroconversion Response In 2019
时间窗: Post-vaccination (at Day 28 timepoint)
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Number of Participants With Seroconversion Response In 2020
时间窗: Post-vaccination (at Day 28 timepoint)
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
次要结局
- Number of Participants With Seroprotection Response in 2019(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
- Geometric Mean Titers (GMTs) at Each Time Point 2019(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
- Geometric Mean Titers (GMTs) at Each Time Point 2020(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
- Number of Participants With Seroprotection Response in 2020(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
研究者
Richard Zimmerman MD
Professor
University of Pittsburgh