NCT01114620已完成4 期
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
研究概览
简要总结
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese male and female adults 65 years of age or older at time of vaccination.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Good general health as assessed by medical history and physical examination.
- •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 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 and for 2 months after study vaccination.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •History of previous administration of a pandemic H1N1 vaccine.
- •Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- •Presence or 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 >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
- •Diagnosed with cancer, or treatment for cancer within three years.
- •Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- •Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary.
- •Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone or equivalent when administered for > 2 weeks. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
- •Receipt of any immunoglobulins and/or any blood products within three 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 within 6 months of receipt of seasonal influenza vaccination.
- •Administration of any vaccines within 30 days before vaccination or planned administration before blood sampling at Day 21 and within 30 days prior to blood sampling at Day
- •Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- •Excessive underweight [Body Mass Index (BMI) < 18.5] or excessive obesity (BMI >= 30).
- •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
- •Clinically or virologically confirmed influenza infection within 12 months preceding the study start.
结局指标
主要结局
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
时间窗: At Day 21
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
时间窗: At Day 21
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Number of Seroprotected Subjects for HI Antibodies
时间窗: At Day 21
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
次要结局
- Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain(At Days 0 and 182)
- Number of Subjects With HI Antibody Concentrations Above the Cut-off Value(At Days 0 and 182)
- Number of Subjects With Medically Attended AEs (MAEs)(During the 21-day (Days 0-20) post-vaccination period)
- Number of Subjects With Abnormal Urine Sampling Parameters(At Day 0 and Day 7)
- Number of Seroprotected Subjects for HI Antibodies(At Days 0 and 182)
- Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value(At Days 0 and 182)
- Number of Days With Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Days With Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With MAEs(During the 42-day (Days 0-41) post-vaccination period)
- Number of Subjects With Potential Immune-mediated Diseases (pIMDs)(During the entire study period (from Day 0 up to Day 182))
- Number of Seroconverted Subjects for HI Antibodies(At Day 182)
- Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease(At Day 21)
- Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease(At Day 182)
- Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels(At Day 0 and Day 7)
- GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease(At Day 182)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease(At Days 0 and 182)
- Number of Subjects With Unsolicited AEs(During the 42-day (Days 0-41) post-vaccination period)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 21-day (Days 0-20) post-vaccination period)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Day 182))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy InfantsTuberculosisNCT01098474GlaxoSmithKline301
终止
3 期
Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in ChildrenInfluenzaNCT01014091GlaxoSmithKline60
已完成
3 期
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in ChildrenInfluenzaNCT00980005GlaxoSmithKline2,116
已完成
3 期
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)InfluenzaNCT00971425GlaxoSmithKline145
已完成
3 期
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and ChildrenInfluenzaNCT02207413GlaxoSmithKline1,886