Influenza Vaccination Effectiveness of a Quadrivalent Inactivated Vaccine in Pregnant Women and Young Infants (Aged 6 Months and Below) During Influenza Season 2019/2020
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 949
- 试验地点
- 1
- 主要终点
- rates of laboratory-confirmed influenza in vaccinated and unvaccinated pregnant women
研究概览
简要总结
Influenza is associated with an increased risk for serious illness, hospitalization and death in pregnant women and young infants. The investigators estimated the effectiveness of a quadrivalent inactivated influenza vaccine (QIV) in pregnant women and their infants in 2019-2020 influenza season. Women were activelly followed during the influenza season on a weekly basis through telephone call in order to collect data about the onset of fever and/or respiratory symptoms by them or their young infants. Polymerase chain reaction testing in pharyngeal samples was offered to pregnant women and infants with influenza-like illness (ILI). A total of 636 pregnant women and 474 infants were studied. A Bayesian beta-binomial model was used.
详细描述
Study period: Influenza 2019-2020 season
The investigators followed actively the pregnant women and their infants in order to collect prospectively data on a weekly basis through phone calls during the entire influenza season.
Definitions:
- ILI was defined as the sudden onset of symptoms and fever, malaise, myalgia or headache, and cough, sore throat or shortness of breath.
- ARI was defined as the presence of at least one respiratory symptom, regardless of fever.
- Febrile episode was defined as the presence of fever only.
- Fever was defined as a temperature of 38.0 C in at least two measurements within 24h.
- The diagnoses of pneumonia and AOM were accepted as reported by the physicians who provided care to the women or their infants.
The 2019-2020 QIV Vaxigrip-Tetra was used to vaccinate pregnant women.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women >18 years old and <45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020
排除标准
- •<18 years old or >45 years old
- •not in stable health
- •already vaccinated against influenza
- •history of Guillain-Barré syndrome
- •history of hypersensitivity to influenza vaccines
- •immunosuppression
- •history of investigational drug <30 days
- •history of immunoglobulins or blood products <3 months
- •fever at day of interview (enrollment day)
结局指标
主要结局
rates of laboratory-confirmed influenza in vaccinated and unvaccinated pregnant women
时间窗: 2019-2020 influenza season
influenza vaccine effectiveness against laboratory-confirmed influenza in pregnant women
rates of laboratory-confirmed influenza in young infants whose mothers were vaccinated and in infants of unvaccinated mothers
时间窗: 2019-2020 influenza season
influenza vaccine effectiveness against laboratory-corfirmed influenza in young infants
次要结局
- rates of acute respiratory infection, influenza-like illness, febrile episode, use of antibiotics, use of antivirals, pneumonia, acute otitis media (for infants only), healthcare seeking and hospitalization in pregnant women and their infants(2019-2020 influenza season)
研究者
Helena Maltezou
Professor
University of Athens