A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,474
- 试验地点
- 28
- 主要终点
- Geometric Mean Titer 30 Days After the Last Study Vaccination
研究概览
简要总结
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
- •For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
- •Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.
排除标准
- •Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
结局指标
主要结局
Geometric Mean Titer 30 Days After the Last Study Vaccination
时间窗: 30 days after the last study vaccination
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
时间窗: 30 days after the last study vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
次要结局
- Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)(7 days after each vaccination)
- Frequency and Intensity of Unsolicited Adverse Events (UAEs)(30 days after each vaccination)
- New Onset of Chronic Illnesses (NOCIs)(6 months after last study vaccination)
- Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B(7 days after each vaccination)
- Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)(7 days after each vaccination)
- Duration of Local and Systemic Solicited Symptoms, Cohort C(7 days after vaccination)
- Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C(7 days after vaccination)
- Serious Adverse Events (SAEs)(6 months after last study vaccination)
- Duration of Local and Systemic Solicited Symptoms, Cohort B(7 days after each vaccination)