TITRE III: TIV Infant/Toddler Response Evaluation - Influenza B Immunogenicity Investigation
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Seroprotection rate (SPR) for B/Victoria vaccine strains
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. Historically, the yearly influenza vaccine that was recommended in children was designed to protect against both kinds of influenza A but only one kind of influenza B. In a series of trials conducted between 2008-09 and 2010-11 (TITRE I, II, and IIB), the TITRE investigators measured antibody response to influenza B in children who were primed with two doses of trivalent inactivated influenza vaccine (TIV) containing B/Yamagata. Overall, the investigators found that 2 doses of vaccine containing B/Yamagata did not adequately prime children for response to the alternate B/Victoria antigen and that subsequent vaccine doses containing B/Victoria-lineage antigen strongly boosted antibodies to the B/Yamagata antigen that was introduced during first immunization priming, but with lower responses to B/Victoria.
For the first time since 2009-10, the recommended B/Victoria component of the seasonal influenza vaccine has been changed, from B/Brisbane/60/2008 to B/Colorado/60/2007 for the coming 2018-19 season. The investigators thus have a unique opportunity to clarify lineage-specific influenza B responses in a well-characterized cohort of children originally primed to Yamagata. The investigators' main interest is to assess whether TITRE I children primed with two doses of B/Yamagata in 2008-09 have since or are now capable of achieving a sufficient antibody response to B/Victoria following a single dose of 2018-19 QIV, ten years after their initial TIV B/Yamagata priming exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child previously completed the TITRE I study in British Columbia or Quebec;
- •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;
- •Parent/guardian is fluent in English/French
排除标准
- •Child has already received the 2018-19 seasonal (TIV or QIV) influenza vaccine;
- •Child has a bleeding condition that would prevent vaccine injection or blood collection;
- •Child has known or suspected immunodeficiency;
- •Child has a suspected or known anaphylactic reaction to any of the vaccine components used in this study;
- •Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child;
- •Child has received immune globulin or other blood products within the prior six weeks;
- •Child has received injected or oral steroids within the prior six weeks defined by more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed;
- •Child has received any live vaccine within 28 days of the study vaccine or is scheduled to receive live vaccine during the study period;
- •Child has received any inactivated vaccine within 14 days of the study vaccine;
- •Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period.
研究组 & 干预措施
influenza vaccine recipients
Participants of an earlier clinical trial (TITRE I) to receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine
干预措施: 2018-19 quadrivalent inactivated influenza vaccine (Biological)
结局指标
主要结局
Seroprotection rate (SPR) for B/Victoria vaccine strains
时间窗: 4-6 weeks after receipt of QIV
SPR based on hemagglutination inhibition (HI) assay for current (B/Colorado/06/2017-like) and prior (B/Brisbane/60/2008-like) Victoria lineage vaccine strains
次要结局
- Geometric mean titre ratio (GMTR) for B/Yamagata vaccine strains(4-6 weeks after receipt of QIV)
- Seroprotection rate (SPR) for A/H1N1 vaccine strains(4-6 weeks after receipt of QIV)
- Seroconversion rate (SCR) for A/H1N1 vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre (GMT) for A/H3N2 vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre (GMT) for A/H1N1 vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre ratio (GMTR) for B/Victoria vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre ratio (GMTR) for A/H3N2 vaccine strains(4-6 weeks after receipt of QIV)
- Seroconversion rate (SCR) for A/H3N2 vaccine strains(4-6 weeks after receipt of QIV)
- Seroconversion rate (SCR) for B/Yamagata vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre (GMT) for B/Victoria vaccine strains(4-6 weeks after receipt of QIV)
- Seroconversion rate (SCR) for B/Victoria vaccine strains(4-6 weeks after receipt of QIV)
- Seroprotection rate (SPR) for B/Yamagata vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre (GMT) for B/Yamagata vaccine strains(4-6 weeks after receipt of QIV)
- Geometric mean titre ratio (GMTR) for A/H1N1 vaccine strains(4-6 weeks after receipt of QIV)
- Seroprotection rate (SPR) for A/H3N2 vaccine strains(4-6 weeks after receipt of QIV)
研究者
Danuta Skowronski
Physician Epidemiologist, Influenza and Emerging Respiratory Pathogens
British Columbia Centre for Disease Control