Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral® (2012/2013 Season) in Adults Aged 18 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
研究概览
简要总结
This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •A male or female 18 years of age and older at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •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
- •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.
- •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.
- •Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- •Acute disease and/or fever at the time of enrolment.
- •Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •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 the vaccine dose.
- •A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
- •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 antiplatelet 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 Fluviral® 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
Fluviral Adults Group
Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
干预措施: Fluviral® (Biological)
Fluviral Elderly Group
Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
干预措施: Fluviral® (Biological)
结局指标
主要结局
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
时间窗: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three 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 influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.
时间窗: At Day 21
MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
时间窗: At Day 0 and Day 21
A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
次要结局
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).(During the 21-day (Days 0-20) post-vaccination period.)
- 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 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).)