Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 3
- 主要终点
- Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.
详细描述
In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.Therefore, there exist no relation between the vaccines administered in this study. As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must satisfy ALL the following criteria at study entry:
- •Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .
- •A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
- •Written informed consent obtained from the subject's parent or guardian. Assent obtained from the subject when applicable.
- •Good general health as established by medical history and clinical examination before entering into the study.
- •Comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
- •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 (i.e., a common-use phone serving multiple rooms or apartments).
- •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
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Child in care
- •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 21 days after any study vaccine administration.
- •Active participation in other clinical trials.
- •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.
- •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 (no laboratory testing required).
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- •An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- •Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
- •Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
- •History of seizures or progressive neurological disease.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Diagnosed with cancer or any chronic severe disease.
- •Previous administration of any H5N1 vaccine.
研究组 & 干预措施
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Influenza vaccine GSK1562902A Formulation 1 (Biological)
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Influenza vaccine GSK1562902A Formulation 2 (Biological)
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ (Biological)
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ Junior (Biological)
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Influenza vaccine GSK1562902A Formulation 1 (Biological)
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ (Biological)
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ Junior (Biological)
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Influenza vaccine GSK1562902A Formulation 2 (Biological)
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ (Biological)
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ Junior (Biological)
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ (Biological)
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
干预措施: Havrix™ Junior (Biological)
结局指标
主要结局
Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.
时间窗: At Day 192.
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Number of Subjects With Any Medically Attended Adverse Events (MAEs)
时间窗: From Day 0 to Day 364.
Any = occurrence of the symptom regardless of intensity grade.
次要结局
- Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.(During a 7-day (Day 0-6) follow-up period after each vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During a 7-day (Day 0-6) follow-up period after vaccination)
- Number of Subjects With Serious Adverse Events (SAEs).(During the entire study period (Day 0 to 364))
- Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10(At Days 0, 42, 182, 192 and 364)
- Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease(At Days 192 and 364)
- Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease(At Days 42, 182, 192 and 364)
- Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease(At Days 192 and 364)
- Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies(At Days 192 and 364)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During Day 0 to Telephone Contact (TC) Day 84 overall.)
- Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)(During the entire study period (Day 0 to 364))
- Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies(At Days 42, 182 192 and 364)
- H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains(At Days 0, 42, 182, 192, 364)
- Mean Geometric Increase for Anti-H5N1 Antibody Titers(At Days 42, 182, 192 and 364)
- Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers(At Days 0, 42, 182 192 and 364)
- H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains(At Days 0, 42, 182, 192, 364)
- Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease(At Days 0,42, 182, 192 and 364)