Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
研究概览
简要总结
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
详细描述
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- •Planned administration of an influenza vaccine other than the study vaccines during the entire study period
- •Previous vaccination against influenza since January
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
- •History of hypersensitivity to a previous dose of influenza vaccine.
- •History of confirmed influenza infection within the last 12 months.
- •Pregnancy.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- •Acute disease at the time of enrolment.
结局指标
主要结局
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
时间窗: During a 30-day (Days 0-29) follow-up period after re-vaccination
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
时间窗: During a 7-day (Days 0-6) follow-up period after re-vaccination
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
时间窗: During a 7-day (Days 0-6) follow-up after re-vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
时间窗: During the entire study period (Days 0-30)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.
次要结局
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.(At Days 0 and 21)
- Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.(At Day 21)
- Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.(At Day 0 and 21)
- Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.(At Day 21)