Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
研究概览
简要总结
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.
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
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
- •Subjects having received Pandemrix at least six months prior to study enrolment.
- •Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- •Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device
排除标准
- •Active participation in other clinical trials.
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- •Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- •Acute disease and/or fever at the time of enrolment:
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •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.
- •History of seizures or progressive neurological disease.
- •Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
- •If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- •Child in care.
研究组 & 干预措施
Fluarix Group
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
干预措施: FluarixTM (Biological)
Havrix Group
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
干预措施: HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old) (Biological)
结局指标
主要结局
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
时间窗: At Day 0 and Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Day 28 data were presented only for the Fluarix Group. Titres were expressed as geometric mean antibody titre.
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
时间窗: At Day 0 and Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data was presented only for the Fluarix Group.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
时间窗: At Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (\< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. Day 28 data were presented for the Fluarix Group only.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
时间窗: At Day 0 and Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
时间窗: At Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only.
次要结局
- Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.(At Day 0 and at Month 6)
- Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.(At Day 0 and at Month 6)
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.(At Month 6)
- Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.(At Day 0 and Month 6)
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.(At Month 6)
- Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.(At Day 0 and at Month 6)
- Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.(At Month 6)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(Within 7 days (Day 0 - Day 6) after vaccination)
- Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.(Within 7 days (Day 0 - Day 6) after vaccination)
- Number of Days With Any Solicited Local Symptoms.(Within 7 days (Day 0 - Day 6) after vaccination)
- Number of Days With Grade 3 Solicited Local Symptoms.(Within 7 days (Day 0 - Day 6) after vaccination)
- Number of Days With Any Solicited General Symptoms.(Within 7 days (Day 0 - Day 6) after vaccination)
- Number of Days With Grade 3 Solicited General Symptoms.(Within 7 days (Day 0 - Day 6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(Within 28 days (Day 0 - Day 27) after vaccination)
- Number of Subjects Reporting Medically-attended Events (MAEs).(During the entire study period (Up to Month 6))
- Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).(During the entire study period (Up to Month 6))
- Number of Subjects Reporting Adverse Events of Special Interest.(During the entire study period (Up to Month 6))
- Number of Subjects Reporting Serious Adverse Events (SAEs).(During the entire study period (Up to Month 6))