A Phase IIIA Study of Immunogenicity and Safety of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in adults 18 years of age and older.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject
- •Male and female adults, 18 years of age and older in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination
排除标准
- •Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
- •Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
- •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.
- •Acute disease and/or fever at the time of enrolment.
- •Significant acute or chronic, uncontrolled medical or psychiatric illness.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
- •Insulin-dependent diabetes mellitus.
- •Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study vaccine dose.
- •A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
- •Presence of an active neurological disorder.
- •History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g. low-dose aspirin, and without a clinically apparent bleeding tendency are eligible
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- •Any known or suspected allergy to any constituent of FLU-Q-QIV and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- •A history of severe adverse reaction to a previous influenza vaccination.
- •Pregnant and/or lactating/nursing female.
- •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
研究组 & 干预措施
FLULAVAL QUADRIVALENT Adult Group
Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
干预措施: FLULAVAL® QUADRIVALENT (Biological)
FLULAVAL QUADRIVALENT Elderly Group
Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
干预措施: FLULAVAL® QUADRIVALENT (Biological)
结局指标
主要结局
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
时间窗: At Day 0 and Day 21
Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
时间窗: At Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
时间窗: At Day 0 and Day 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.
时间窗: At Day 21
SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
次要结局
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Day 0 - Day 20 after vaccination).)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).(During the 21-day (Days 0-20) post-vaccination period.)