Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarix™ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrix™
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 8
- 主要终点
- Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
研究概览
简要总结
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 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
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
- •Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
- •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Parent/LAR 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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •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 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.
- •Child in care.
研究组 & 干预措施
Fluarix 6-11 months Group
Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine
干预措施: Fluarix™ (Biological)
Fluarix 12-35 months Group
Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine
干预措施: Fluarix™ (Biological)
Fluarix 3-9 years Group
Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine
干预措施: Fluarix™ (Biological)
Havrix Junior 6-11 months Group
Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine
干预措施: Havrix™ Junior (Biological)
Havrix Junior 12-35 months Group
Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine
干预措施: Havrix™ Junior (Biological)
Havrix Junior 3-9 years Group
Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine
干预措施: Havrix™ Junior (Biological)
结局指标
主要结局
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
时间窗: Day 0 and 28
Antibody titers were expressed as Geometric mean titers (GMTs).
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
时间窗: Day 0-28
Seropositivity was defined as antibody titers greater than or equal to 1:10.
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
时间窗: Day 0-28
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 H1N1 in All Subjects Receiving Fluarix Vaccine
时间窗: Day 28
A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
时间窗: Day 28
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
次要结局
- HI Antibody Titers Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
- HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
- Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
- Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
- Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine(Day 28)
- Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Month 6)
- Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
- Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
- Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine(Day 28)
- Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Month 6)
- Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
- Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
- Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
- Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
- Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix(Day 28)
- Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Month 6)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 7 days (Day 0 - 6) after vaccination)
- Duration of Any Solicited Local Symptom(During the 7 days (Days 0 - 6) after vaccination)
- Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 7 days (Days 0-6) after vaccination)
- Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms(During a 7-day follow-up period (Day 0-6) after vaccination)
- Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During a 28 day follow-up period (Day 0-27) after vaccination)
- Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest(During the entire study period (up to Month 6))
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Up to Month 6)