Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Baseline and post-vaccination (6 weeks) mucosal anti-influenza antibodies from nasal samples as measured by: 1. Anti-HA head antibody quantitative ELISA IgA, IgG 2. Anti-HA stalk antibody quantitative ELISA IgA IgG 3. Anti-NA antibody quantitati...
研究概览
简要总结
Background:
The influenza (flu) virus infects millions around the world every year. Children are at increased risk of complications from the flu. The flu vaccine protects against influenza, but the vaccine can be improved. Researchers want to learn more about children s mucosal and systemic immunity after flu vaccination. This could help to develop more effective flu vaccines in the future.
Objective:
To learn what happens in kids immune systems after receiving a flu vaccine.
Eligibility:
Children ages 2-17 who have received a flu vaccine in the past and plan to get the current seasonal flu vaccine given by injection.
Design:
All study visits will take place at home and communication with the study team will be done via phone or videoconference.
Participants will review medical history and flu vaccination history with the study team.
Participants will get the flu vaccine at their local doctor s office or pharmacy. They will not be given the vaccine in this study.
Participants will complete an electronic survey to give details about the date and type of flu vaccine received.
Participants will collect nasal and fingerstick samples at home. They will collect 4 nasal samples and 3 fingerstick samples over 6 months: once before they get the flu vaccine and 2-3 times after they get the vaccine. They will use collection kits that include instructions, sample collection supplies, and shipping materials. They will ship all samples back to NIH with all costs covered by NIH.
Participation will last for 6 months.
Compensation is provided.
详细描述
Title:
Natural History of Systemic and Nasal Mucosal Immunity after Influenza Vaccination in a Pediatric Population
Study Description:
While adults are heavily represented in influenza vaccine studies, there are limited studies in the pediatric population. This study will characterize the changes in nasal and systemic immunity after influenza vaccination in a pediatric population.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to enroll in this study, an individual must meet all of the following criteria:
- •>= 2 years of age and < 18 years of age at the time of enrollment.
- •Completed a previous influenza series in the past and therefore requires only one seasonal influenza vaccine every year.
- •Planning to receive the current seasonal inactivated influenza vaccine given by injection.
- •Parent or guardian willing and able to provide verbal consent.
- •Willing and able to undergo home blood micro-sampling and nasal sampling.
- •Willing to have samples stored for future research.
- •Parent/guardian able to proficiently speak, read, and write English.
排除标准
- •Any individual who meets any of the following criteria will be excluded from participation in this study:
- •Already received the current season s influenza vaccine.
- •Planning to receive the current seasonal live attenuated influenza vaccine (LAIV).
- •Self-reported pregnancy or breastfeeding.
- •Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.
研究组 & 干预措施
12-17 years of age
12-17 years of age
2-6 years of age
2-6 years of age
7-11 years of age
7-11 years of age
结局指标
主要结局
Baseline and post-vaccination (6 weeks) mucosal anti-influenza antibodies from nasal samples as measured by: 1. Anti-HA head antibody quantitative ELISA IgA, IgG 2. Anti-HA stalk antibody quantitative ELISA IgA IgG 3. Anti-NA antibody quantitati...
时间窗: 6 weeks
Mucosal anti-influenza antibodies
Baseline and post-vaccination (6 weeks) systemic anti-influenza antibodies as measured by: 1. Anti-HA head antibody quantitative ELISA IgM, IgG, IgA 2. Anti-HA stalk antibody quantitative ELISA IgM, IgG, IgA 3. Anti-NA antibody quantitative ELIS...
时间窗: 6 weeks
Systemic anti-influenza antibodies
次要结局
- post-vaccination systemic anti-influenza antibodies(24 weeks)
- post-vaccination mucosal anti-influenza antibodies(24 weeks)