A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340273A and GSK2340274A in Adults Aged 18 Years and Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,343
- 试验地点
- 15
- 主要终点
- Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain
研究概览
简要总结
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.
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.
- •Safety laboratory test results within the parameters specified in the protocol.
- •Satisfactory baseline medical assessment by history and physical examination.
- •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 documented 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 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, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Presence of a temperature >= 38.0ºC (>=100.4ºF), 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 (no laboratory testing required).
- •Receipt of systemic glucocorticoids within 1 month 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 outside of 24 hours prior to vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- •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 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 not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccines.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine/product, 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 the first vaccination.
- •Lactating or nursing women.
研究组 & 干预措施
GSK2340273A F1_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340273A (Biological)
GSK2340273A F2_2D Group
Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340273A (Biological)
GSK2340274A F1_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340274A (Biological)
GSK2340274A F1_2D Group
Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340274A (Biological)
GSK2340274A F2_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: Saline placebo (Biological)
GSK2340274A F1_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: Saline placebo (Biological)
GSK2340273A F1_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: Saline placebo (Biological)
GSK2340274A F2_2D Group
Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340274A (Biological)
GSK2340273A F2_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
干预措施: Saline placebo (Biological)
GSK2340273A F3_2D Group
Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340273A (Biological)
GSK2340274A F2_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
干预措施: GSK2340274A (Biological)
GSK2340273A F2_1D Group
Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
干预措施: GSK2340273A (Biological)
结局指标
主要结局
Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain
时间窗: At Day 21
SCF was defined as the fold increase in serum HI geometric mean ratio (mean\[log10(POST/PRE)\]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (\>60y).
Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain
时间窗: At Day 21
A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects \> 64 years.
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain
时间窗: At Day 21
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (\>60y).
Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain
时间窗: At Day 21
A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects \> 60 years.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain
时间窗: At Day 21
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (\>64y).
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (\>60y).
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (\>64y).
Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain
时间窗: At Day 21
SCF was defined as the fold increase in serum HI geometric mean ratio (mean\[log10(POST/PRE)\]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (\>64y).
次要结局
- Titers for HI Antibodies Against A/California Strain(At Days 0 and 21)
- Adjusted GMT Ratios for A/California Strain(At Day 21)
- Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain(At Days 0 and 21)
- Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain(At Day 42)
- Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain(At Days 0 and 21)
- Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain(At Day 182)
- Titers for HI Antibodies Against the A/California Virus Strain(At Days 0 and 182)
- Adjusted GMT Ratios of A/California Virus Strain(At Day 21)
- Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain(At Days 0 and 182)
- Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain(At Day 21)
- Adjusted GMT Ratios of A/California Strain(At Day 21)
- Number of Subjects With Any and Grade 3 Solicited General Symptoms(During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age)
- Number of Subjects With Abnormal Biochemical and Haematological Levels(At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 84-day (Days 0-83) post-vaccination period)
- Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain(At Days 0 and 182)
- Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain(At Days 0 and 42)
- Adjusted GMT Ratios for A/California Virus Strain(At Day 21)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Day 385))
- Number of Seroconverted (SCR) Subjects for HI Antibodies(At Day 182)
- Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain(At Day 21)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age)
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)(Days 0 to 365)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs)(Days 0 to 385)