The Safety and Immune Response to Influenza Vaccination in Pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer.
研究概览
简要总结
The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant female aged ≥ 18 years old.
- •Subject is pregnant for at least 3 months, inclusive.
- •Subject is willing and able to adhere to visit schedules and all study requirements.
- •Subject has read and signed the study-specific informed consent.
排除标准
- •Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion;
- •Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia;
- •Subject received any influenza vaccine within the previous 6 months;
- •Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine;
- •Subject or her family has the history of Guillain-Barré Syndrome;
- •Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
- •Subject with influenza-like illness as defined by the presence of fever (temperature over 38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- •Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- •Subject has immunodeficiency or is under immunosuppressive treatment.
- •Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination;
- •Subject received any blood products, including immunoglobulin, in the past 3 months before consent;
- •Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
研究组 & 干预措施
AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose
干预措施: AdimFlu-S Influenza Vaccine (Biological)
结局指标
主要结局
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer.
时间窗: Immunogenicity profile was assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. Moreover, the HAI titer of the cord blood was also measured and compared with the maternal blood sample.
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. Immunogenicity profile will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period.
次要结局
- The secondary endpoint is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S.(The safety information is collected from the day of vaccination to 8 weeks after the delivery.)