Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- immunogenicity of a A(H1N1)v influenza vaccine, administered in patients with cystic fibrosis
研究概览
简要总结
Multicenter prospective cohort of approximately 1000 cystic fibrosis patients followed in the Ile de France during the 2009-2010 influenza season with the main objective to assess the effectiveness of antiviral vaccination (H1N1). All subjects will be included, without excluding factor. In particular populations at risk are additional infants 6 to 23 months, pregnant women and lung transplant will also be included. These people will be vaccinated with un-adjuvanted vaccine.
If flu symptoms until the results of PCR to confirm or refute the diagnosis of influenza, oseltamivir is administered in accordance with official recommendations and based on the results of the pharmacokinetic study.
详细描述
Main objective : To investigate the clinical efficacy of pandemic influenza vaccine (H1N1) v patients with cystic fibrosis (CF)
Secondary objectives : Vaccine research
- Measure the adherence of this population to the pandemic influenza vaccination
- Measure the tolerance of the pandemic influenza vaccine (H1N1) v
- Study the immunogenicity vaccine against the H1N1 variant and factors associated with vaccine response
Epidemiological and clinical study :
- Describe the incidence of asymptomatic forms of influenza A (H1N1) among unvaccinated and identify factors associated with the occurrence of these forms in patients with cystic fibrosis
- Describe the impact of influenza A (H1N1) in vaccinated and unvaccinated
- Characterizing the clinical expression of the influenza pandemic period in vaccinated and unvaccinated and identify factors associated with the occurrence of severe forms in patients with cystic fibrosis
- Characterize the serological response in patients who have a proven H1N1
- Characterize the impact of influenza A (H1N1) on the lung disease patients in the short and medium term
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cystic fibrosis
排除标准
- 未提供
研究组 & 干预措施
Influenza vaccination
Influenza vaccination in patients with cystic fibrosis
干预措施: influenza vaccination (Biological)
结局指标
主要结局
immunogenicity of a A(H1N1)v influenza vaccine, administered in patients with cystic fibrosis
时间窗: Day 21 for patients vaccinated with one dose of vaccine or Day 42 for patients vaccinated with 2 doses
Immunogénicity was evaluated as: Seroprotection rate (defined by the percentage of patients with serum anti-haemagglutinin antibody titre ≥ 1/40e), seroconversion rate (defined by the percentage of patients with antibody titre \<1/10e before vaccination and ≥ 1/40e after vaccination or with a titre ≥ 1/10e before vaccination and a titre at least 4-fold greater after vaccination) and seroconversion factor (defined by the ratio of the post/pre vaccination geometric mean titres) tested 3 weeks after the last influenza vaccination
次要结局
- Vaccination tolerance: pain, erythema, fever, other general reactions(1 year after vaccination)
- Longitudinal lung function evaluation, as asses(Before and 1 year after the day of vaccination)