NCT00980005已完成3 期
Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,116
- 试验地点
- 29
- 主要终点
- Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
研究概览
简要总结
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
- •A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- •Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
- •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 any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
- •Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- •Child in care
- •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.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •History of hypersensitivity to any vaccine.
- •History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Acute disease and/or fever at the time of enrolment.
- •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.
- •History of chronic alcohol consumption and/or drug abuse.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
研究组 & 干预措施
Flulaval Group
Experimental
subjects received Flulaval™ vaccine according to their priming status and age:
- 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
- 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
干预措施: GSK investigational vaccine GSK1557482A (Biological)
Fluzone Group
Active Comparator
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
- 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
- 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
干预措施: Fluzone® (Biological)
结局指标
主要结局
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
时间窗: At Day 0 and 28 after last vaccine dose.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
时间窗: At Day 28 after last vaccine dose.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
次要结局
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).(During a 4-day follow-up period (Days 0-3) after vaccination.)
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.(During a 4-day follow-up period (Days 0-3) after vaccination.)
- Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.(At Day 0 and 28 after last vaccine dose.)
- Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.(At Day 0 and 28 after last vaccine dose.)
- Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.(At Day 28 after last vaccine dose.)
- Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.(At Day 0 and 28 after last vaccine dose.)
- Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.(At Day 0 and at Day 28 after last vaccine dose)
- Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).(During a 4-day follow-up period (Days 0-3) after vaccination.)
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.(During a 28 day follow-up period (Days 0-27) after vaccination.)
- Number of Subjects Reporting Medically Attended Adverse Events (MAEs).(During the entire study period (From Day 0 up to Day 180).)
- Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.(At Day 0 and at Day 28 after last vaccine dose)
- Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).(During a 4-day follow-up period (Days 0-3) after vaccination.)
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).(During a 28 day follow-up period (Days 0-27) after vaccination.)
- Number of Subjects Reporting Serious Adverse Events (SAEs).(During the entire study period (From Day 0 up to Day 180).)
研究者
研究点 (29)
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