Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Number of Subjects With Solicited Local Symptoms.
研究概览
简要总结
The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects who the investigator believes can and will comply with the requirements of the protocol
- •A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
- •Access to a telephone for scheduled follow-up telephone contacts
- •Ability to provide written informed consent
- •Healthy subjects as established by medical history and physical examination before entering into the study
- •If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.
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 dose of study vaccine, or planned use during the study period
- •Receipt of systemic glucocorticoids within 30 days of study enrollment
- •Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
- •Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
- •Previous vaccination against influenza (2007-2008 influenza season)
- •History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
- •History of Guillain-Barre Syndrome (GBS)
- •Acute disease, febrile illness, or upper respiratory infection at screening.
- •History of splenectomy
- •Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
- •Acquired or congenital coagulation disorders or known thrombocytopenia
- •Current treatment with warfarin or heparin derivatives
- •Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
- •Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza
研究组 & 干预措施
GSK 1388442A Group
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Trivalent influenza vaccine GSK 138842A (Biological)
Fluarix Group
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Fluarix (Biological)
结局指标
主要结局
Number of Subjects With Solicited Local Symptoms.
时间窗: During the 7-day (Days 0-6) post vaccination period
Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
Number of Subjects With Solicited General Symptoms.
时间窗: During the 7-day (Days 0-6) post vaccination period
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
时间窗: During the 90-day (Days 0-89) post-vaccination period
Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Number of Subjects With Serious Adverse Events (SAEs).
时间窗: During the entire study period (Days 0-182)
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. Any SAE = any SAE regardless of intensity or relationship to vaccination.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
时间窗: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.
时间窗: At Day 21
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Number of Subjects With Medically Attended Adverse Events (MAEs).
时间窗: During the entire study period (Days 0-182)
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
Number of Subjects With New Onset of Chronic Diseases (NOCDs).
时间窗: During the entire study period (Days 0-182)
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.
时间窗: At Day 0 and Day 21
GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
次要结局
未报告次要终点