Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Immune response
研究概览
简要总结
Seasonal influenza vaccination was used to assess whether induction of immunity as well as the rate of side effects is influenced by the timing of the last training session before vaccination. Healthy athletes were vaccinated with the tetravalent influenza vaccine and blood samples were collected before, 1, 2 and 26 weeks after vaccination. The athletes were randomly assigned to vaccination within 2 hours after the last training session ("2h") vs. vaccination after a resting period of at least 26 hours ("26h"). All participants documented side effects and training restrictions. Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •performance-oriented training on at least five days a week, healthy athletes
排除标准
- •current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases
研究组 & 干预措施
26h
The athletes of the second group were vaccinated after an entire day (between 24 and 26 hours) after their last training session.The vaccine was administered via intra-muscular injection into the deltoid muscle of the non-dominant arm in a standardized manner.
干预措施: Influenza Vaccination (Biological)
2h
The participants were asked to report for their vaccination immediately after an intensive bout of training (not later than two hours after). The influenza vaccine was administered via intra-muscular injection into the deltoid muscle of the non-dominant arm in a standardized manner.
干预措施: Influenza Vaccination (Biological)
结局指标
主要结局
Immune response
时间窗: 26 weeks
Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.
Rate of side effects
时间窗: 2 weeks
All participants documented side effects and training restrictions.
次要结局
未报告次要终点