A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children 6 Months to Less Than 9 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 31
- 主要终点
- Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
研究概览
简要总结
The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.
This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.
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
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female children 6 months to less than 9 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject's parent/ legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- •Good general health as established by medical history and clinical examination before entering into the study.
- •Safety laboratory test results within the parameters specified in the protocol.
- •Parent/ LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- •Subjects who the investigator believes that their parent(s)/ LAR can and will comply with the requirements of the protocol.
- •Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.
排除标准
- •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, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- •Presence of a temperature >= 38.0ºC (>=100.4ºF) by any route or method, 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 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids 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.
- •An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- •Administration of any licensed vaccine within 4 weeks before the first dose of study vaccine, with the exception of seasonal influenza vaccine.
- •Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
- •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, 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.
- •Child in care.
研究组 & 干预措施
Arepanrix/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
干预措施: GSK2340274A (Biological)
GSK2340273A/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
干预措施: GSK2340273A (Biological)
Arepanrix/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
干预措施: GSK2340274A (Biological)
GSK2340273A/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
干预措施: GSK2340273A (Biological)
结局指标
主要结局
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
时间窗: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
时间窗: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
时间窗: At Day 42
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
时间窗: At Day 42
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
时间窗: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
时间窗: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
时间窗: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
时间窗: At Day 21
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.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
时间窗: At Day 42
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.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
时间窗: At Day 42
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.
次要结局
- Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis(At Day 0 (PRE) and at Day 21)
- Number of Seropositive Subjects for HI Antibodies - First Analysis(At Day 0 (PRE) and at Day 42)
- Number of Seropositive Subjects for HI Antibodies - Second Analysis(At Day 0 (PRE) and at Day 42)
- Number of Seropositive Subjects for HI Antibodies(At Day 0 (PRE) and at Day 182)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis(At Day 0 (PRE) and at Day 21)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis(At Day 0 (PRE) and at Day 42)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis(At Day 0 (PRE) and at Day 42)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain(At Day 0 (PRE) and at Day 182)
- Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain(At Day 182)
- Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain(At Day 0 (PRE) and at Day 182)
- Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain(At Day 182)
- Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain(At Day 0 (PRE) and at Day 42)
- Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain(At Day 0 (PRE) and at Day 42)
- Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations(At Day 0 (PRE) and at Day 42)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis(At Day 0 (PRE), at Day 7 and at Day 21)
- Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis(At Day 0 (PRE), at Day 7 and at Day 21)
- Number of Subjects With Haematological Laboratory Abnormalities - First Analysis(At Day 0 (PRE), at Day 7, at Day 21 and at Day 42)
- Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis(At Day 0 (PRE), at Day 7, at Day 21 and at Day 42)
- Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis(At Day 0 (PRE), at Day 7 and at Day 21)
- Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis(At Day 0 (PRE), at Day 7, at Day 21 and at Day 42)
- Number of Subjects With Haematological Laboratory Abnormalities(At Day 182)
- Number of Subjects With Biochemical Laboratory Abnormalities(At Day 182)
- Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis(Within 21 days (Days 0-20) post vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis(Within 42 days (Days 0-41) post vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis(Within 41 days (Days 0-40) post vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 84 days (Days 0-83) post vaccination)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis(Within 21 days (Days 0-20) post vaccination)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis(Within 41 days (Days 0-40) post vaccination)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis(Within 42 days (Days 0-41) post vaccination)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs)(Throughout the entire study period (Day 0 - Day 385))
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis(Within 21 days (Days 0-20) post vaccination)
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis(Within 42 days (Days 0-41) post vaccination)
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis(Within 42 days (Days 0-41) post vaccination)
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)(Throughout the entire study period (Day 0 - Day 385))
- Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis(Within 21 days (Days 0-20) post vaccination)
- Number of Subjects With Serious Adverse Events (SAEs) - First Analysis(Within 42 days (Days 0-41) post vaccination)
- Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis(Within 42 days (Day 0-41) post vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study period (Day 0 - Day 385))