A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,048
- 试验地点
- 39
- 主要终点
- Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
研究概览
简要总结
The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
详细描述
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
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 —（Adult, Older 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.
- •Written informed consent obtained from the subject.
- •Male and female adults, >= 18 years of age at the time of the first vaccination.
- •Satisfactory baseline medical assessment by history and physical examination.
- •Safety laboratory test results within the parameters specified in the protocol.
- •Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document.
- •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.
- •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 first 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
- •Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- •Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
- •With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day
- •Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day
- •Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.
- •Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).
- •Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
- •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 a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- •Diagnosed with cancer, or treatment for cancer, within 3 years.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.
- •Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment 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 are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- •History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- •With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day
- •Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day
- •Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.
- •Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •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.
- •Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination.
- •Lactating or nursing women.
研究组 & 干预措施
GSK2340273A Group
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
干预措施: GSK2340273A (Biological)
GSK2340274A Group
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
干预措施: GSK2340274A (Biological)
结局指标
主要结局
Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
时间窗: From Day 14 post-vaccination up to study end (at Day 385)
The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
时间窗: At Day 21
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
时间窗: At Day 21
SCF was defined as the fold increase in serum HI 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, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
次要结局
- Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of A/California Influenza Related Cases(From Day 0 up to the end of ILI surveillance (Day 385))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)(Throughout the entire study period (Day 0 - Day 385))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 42-day (Days 0-41) post-vaccination period)
- Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 42)
- Number of ILI Symptoms in All Reported ILI Cases(From Day 14 post-vaccination through the end of ILI surveillance (Day 385))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels(At Days 7 and 21)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs)(Throughout the entire study period (Day 0 - Day 385))
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study period (Day 0 - Day 385))