Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 Years and Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 6
- 主要终点
- Percentage of Seroconverted (SCR) Subjects for HI Antibodies
研究概览
简要总结
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
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
- 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
- •A male or female aged 18 years or above at the time of the first vaccination.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
- •Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •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 series.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Presence of an axillary temperature >= 37.5ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
- •Diagnosed with cancer, or treatment for cancer, within the past 3 years.
- •Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- •Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above.
- •Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- •Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
- •Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
- •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- •An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- •Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- •Administration of any vaccines within 30 days before vaccination.
- •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- •Pregnant or lactating female
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
结局指标
主要结局
Percentage of Seroconverted (SCR) Subjects for HI Antibodies
时间窗: At Day 21
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies
时间窗: At Day 21
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
时间窗: At Day 21
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
次要结局
- Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Day 364)
- Number of Seroconverted (SCR) Subjects for HI Antibodies(At Day 364)
- Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels(At Day 364)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 21-days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 in M6 groups))
- Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Day 364)
- Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease(At Days 0, 21 and 42)
- Duration of Solicited Local Symptoms Occurring in Response to Individual Doses(During the 7-day (Days 0-6) post-vaccination period following each dose)
- Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease(At Day 203)
- Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Day 364)
- Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)(From Day 0 up to Day 546)
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to Day 546)
- Number of Subjects With Adverse Events of Specific Interest (AESIs)(From Day 0 up to Day 364)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Duration of Solicited General Symptoms Occurring in Response to Individual Doses(During the 7-day (Days 0-6) post-vaccination period following each dose)
- Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09(At Day 21 and 42)