Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
研究概览
简要总结
The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 years old. The effects of prior infection and or prior season vaccination will be examined. Children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).
详细描述
All children will have baseline blood samples drawn and will then be vaccinated with licensed and approved influenza vaccines. Following the recommendation from the Advisory Committee on Immunization Practices, children 5-8 years old will preferentially receive live attenuated influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed influenza vaccine will be excluded from the study.
The children will have their blood drawn between 2 and 4 times total over the course of two months in order to test their immune response to the vaccine. Between approximately December and April, study participants will be contacted weekly to monitor for any new respiratory illnesses with cough, and if present, nasal and throat swabs will be collected to test for influenza.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)
- •Enrolled in either the immune response study or the vaccine effectiveness study conducted at the site in the 2013-14 influenza season
- •If enrolled in the vaccine effectiveness study the previous season must have either been vaccinated and infected with influenza or unvaccinated and uninfected with influenza
排除标准
- •Children with contraindications to either the quadrivalent live attenuated influenza vaccine or to the trivalent inactivated influenza vaccine will be excluded.
- •Anyone unwilling or unable to complete all required study activities including informed consent
- •Subjects who already received the influenza vaccine for the 2014-15 season
研究组 & 干预措施
IIV 2014-15
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
干预措施: IIV (Biological)
LAIV 2014-15
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
干预措施: LAIV (Biological)
结局指标
主要结局
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
时间窗: Change from Baseline to 28 days
次要结局
- Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)(Day 7)
- Polymerase Chain Reaction (PCR) Confirmed Influenza Illness(Onset >13 days after vaccination and before April 1, 2015)
- Antibody Dependent Cellular Cytotoxicity (ADCC) Titers(Change from Baseline to 28 days)
研究者
Edward Belongia
Director of Center for Clinical Epidemiology and Population Health
Marshfield Clinic Research Foundation