Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 10
- 主要终点
- Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
研究概览
简要总结
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female children 10 to < 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
- •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.
- •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 they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.
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.
- •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 by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
- •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 (first dose of study vaccine), 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 6 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 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
- •Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
- •Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, 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 consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- •Child in care.
研究组 & 干预措施
AREPANRIX-ADJUVANTED F1 2D GROUP
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
干预措施: GSK Biologicals' Influenza investigational vaccine GSK2340274A (Biological)
AREPANRIX-ADJUVANTED F1 2D GROUP
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
干预措施: Placebo (saline) (Biological)
AREPANRIX-ADJUVANTED F2 2D GROUP
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
干预措施: GSK Biologicals' Influenza investigational vaccine GSK2340274A (Biological)
AREPANRIX-ADJUVANTED F2 2D GROUP
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
干预措施: Placebo (saline) (Biological)
AREPANRIX-ADJUVANTED F2 3D GROUP
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
干预措施: GSK Biologicals' Influenza investigational vaccine GSK2340274A (Biological)
AREPANRIX-UNADJUVANTED F2 2D GROUP
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
干预措施: GSK Biologicals' Influenza investigational vaccine GSK2340273A (Biological)
AREPANRIX-UNADJUVANTED F2 2D GROUP
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
干预措施: Placebo (saline) (Biological)
结局指标
主要结局
Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
时间窗: At Day 0 and Day 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
时间窗: At Day 21
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain
时间窗: At Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
次要结局
- HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain(At Day 0 and Day 21)
- GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1(At Day 182)
- GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity(At Day 189)
- Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1(At Day 0, Day 182 and Day 189)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs(During the 7-day (Days 0-6) post-vaccination period following booster dose)
- GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity(At Day 189)
- Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)(During the entire study period (Days 0-364) following first vaccination)
- Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1(At Day 42)
- Number of Subjects Reporting Any and Grade 3 Solicited Local AEs(During the 7-day (Days 0-6) post-vaccination period following booster dose)
- Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges(At Days 0, 21, 42, 182 and 189)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(During the entire study period (Day 0 to Day 364))
- The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1(At Day 0 and Day 42)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)(During the 7-day (Days 0-6) post-vaccination period following each dose)
- Number of Subjects Reporting Any Medically Attended Events (MAEs)(During the entire study period (Days 0-364) following the first vaccination)
- Number of Subjects Reporting Any Unsolicited AEs(During the 21-day (Days 0-20) follow-up period after booster vaccination.)
- Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain(At Day 189)