Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Quadrivalent Influenza Vaccine FLU Q-QIV (GSK2282512A) When Administered Intramuscularly to Adults 18 Years of Age and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,707
- 试验地点
- 13
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
研究概览
简要总结
This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines.
This study will also evaluate the lot-to-lot consistency of three vaccine lots.
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
- Double (Participant, Investigator)
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
- •A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study.
- •Written informed consent obtained from the subject.
- •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 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 an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period.
- •Planned administration or administration of a licensed vaccine within 30 days before study vaccination.
- •Prior receipt of 2010/2011 influenza vaccine.
- •Receipt of any investigational or approved influenza vaccine within six months of the first study visit.
- •Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
- •Presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •Fever at the time of enrolment.
- •Acute disease at the time of enrolment
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
研究组 & 干预措施
GSK2282512A 1 Group
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Quadrivalent seasonal influenza vaccine GSK2282512A (Biological)
GSK2282512A 2 Group
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Quadrivalent seasonal influenza vaccine GSK2282512A (Biological)
GSK2282512A 3 Group
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Quadrivalent seasonal influenza vaccine GSK2282512A (Biological)
Victoria Strain FluLaval Group
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: FluLavalTM-VB (Biological)
Yamagata Strain FluLaval Group
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: FluLavalTM-YB (Biological)
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
时间窗: At Day 0 (D0) and at Day 21 (D21) post vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.
次要结局
- Number of Subjects With Medically-attended Adverse Events (MAEs)(From the beginning of the study until study end (from Day 0 to Day 180))
- Number of Subjects With Related Medically-attended Adverse Events (MAEs)(From the beginning of the study until study end (from Day 0 to Day 180) .)
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)(From the beginning of the study until study end (from Day 0 to Day 180) .)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(From the beginning of the study until study end (from Day 0 to Day 180))
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease(At Day 0 (D0) and at Day 21 (D21) after vaccination.)
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata(At Day 0 (D0) and at Day 21 (D21) after vaccination)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata(At Day 21 (D21) post vaccination.)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease(At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.)
- Number of Seroconverted Subjects Against 4 Strains of Influenza(At Day 21 (D21) after vaccination.)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease(At Day 21 (D21) post vaccination.)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 21-day (Days 0-20) follow-up period after vaccination)
- Number of Days With Solicited Local Symptoms After Vaccination.(Within the 7-day follow-up period after vaccination (Days 0-6))
- Number of Days With Solicited General Symptoms After Vaccination(Within the 7-day follow-up period after vaccination (Days 0-6))
- Number of Days With Unsolicited Adverse Events (AEs) After Vaccination(Within the 21-day (Days 0-20) follow-up period post vaccination)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata(At Day 0 (D0) and at Day 21 (D21) post vaccination.)
- Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata(At Day 21 (D21) after vaccination.)