TITRE IIB Follow-Up: TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
研究概览
简要总结
Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.
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
- 29 Months 至 51 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child previously participated in the TITRE II study;
- •Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- •Child is available and can complete all relevant procedures during the study period;
- •Parent or legal guardian is available and can be reached by phone during the study period;
- •Parent/guardian provides written informed consent;
- •And, parent/guardian is fluent in English/French.
排除标准
- •Child has already received the 2010-11 seasonal (TIV) influenza vaccine
- •Child has received immune globulin or other blood products within the prior six weeks;
- •Child has received injected or oral steroids within prior six weeks;
- •Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period;
- •Or, child has a recently acquired health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child.
结局指标
主要结局
The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses
时间窗: 4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV)
The seroprotection rate based on hemagglutination inhibition (HI) assay for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses following a single age-appropriate dose of 2010-11 TIV containing B/Brisbane/60/2008(Victoria)-like virus in young children originally primed with two doses of 2008-09 TIV containing B/Florida/4/2006(Yamagata) and who had received a single dose of the 2009-10 TIV containing B/Brisbane/60/2008(Victoria) virus
次要结局
- Antibody response to other relevant TIV components(4-6 weeks following a single dose of 2010-11 TIV)