A Phase 1, Double-blind, Active-controlled, Randomized Study in Healthy Adults to Evaluate Safety, Tolerability, and Immunogenicity of a Trivalent and Quadrivalent Cell-based Virosomal Subunit Influenza Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Number of participants with Solicited Systemic Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.
详细描述
This is a double-blind and randomized study in healthy adults. The duration of study will be approximately 90 days per participant. The study will include 4 visits: Day 1 (for vaccination), Day 4, Day 22 and day 90 (Follow-up visits). Safety and tolerability will be assessed by the rate of solicited, unsolicited, and serious adverse events.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults
- •Body Mass Index <= 30 kilogram per square meter (kg/m^2)
- •Written informed consent
排除标准
- •Vaccination with 2013/2014-seasonal influenza vaccine and/or receipt of any vaccine in the 4 weeks preceding receipt of study vaccine and/or any vaccination planned within 3 weeks from the study vaccine
- •Diagnosis (by rapid test, performed at clinic/hospital laboratory) of laboratory-confirmed influenza in the 2013/2014 season
- •Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- •Acute febrile illness (greater than or equal to 38.0 celcius)
- •Pregnancy as assessed by urine pregnancy test before vaccination, or lactation. Women of childbearing potential (that is, not surgically sterilized/hysterectomized or post-menopausal for more than 2 years) will be excluded if one of the following criteria is met: 1). Intention to become pregnant during the course of the study or to donate eggs (ova, oocytes) for the purposes of assisted reproduction 2). If heterosexually active, not using or not willing to continue using a medically reliable method of contraception for the entire study duration (up to 90 days). A medically reliable method of contraception includes oral contraceptive preparation (for example pills), hormonal implant, progestative injection, patch contraceptive formulation, an intrauterine device, concomitant use of barrier method and spermicide, or another method considered sufficiently reliable by the investigator in individual cases
结局指标
主要结局
Number of participants with Solicited Systemic Adverse Events (AEs)
时间窗: Up to Day 8
The solicited systemic AEs headache, fatigue, myalgia, malaise, and shivering/rigors will be noted in the participant Diary from Day 1 to Day 8. Fever (defined as body temperature greater than 38.0 Celsius) is another solicited systemic AE. Local AEs will be graded according to severity as mild (grade 1), moderate (grade 2), severe (grade 3) and potentially life threatening (grade 4).
Number of participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 22
Unsolicited AEs are all AEs the participants are not specifically asked about in the participant Diary.
Number of participants with Solicited Local Adverse Events (AEs)
时间窗: Up to Day 8
The local AEs pain, erythema, and induration at the study vaccine injection site will be noted in the participant Diary from Day 1 to Day 8. The extent (largest diameter) of any redness or induration should be measured daily and recorded, along with any functional limitation of activity. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Number of participants with Serious Adverse Events (SAEs)
时间窗: Up to Day 90
The SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization or is a suspected transmission of any infectious agent via medicinal product.
次要结局
- Number of Participants with Seroconversion(Day 22)
- Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies(Baseline and Day 22)
- Number of Participants with Seroprotection(Baseline and Day 22)