NCT01198756已完成3 期
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,109
- 试验地点
- 34
- 主要终点
- Number of Subjects Seroconverted Against 4 Strains of Influenza Disease
研究概览
简要总结
This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
- •A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
- •Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
- •Written informed assent obtained from the subject if/as required by local regulations.
- •Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
- •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 urine 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
- •Child in care
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
- •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.
- •History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
- •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.
- •Fever at the time of enrolment.
- •Acute disease at the time of enrolment.
- •Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- •Pregnant or lactating female.
- •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.
- •Ongoing aspirin therapy.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
结局指标
主要结局
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease
时间窗: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
时间窗: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
次要结局
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease(At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata(At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata(At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease(At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Number of Subjects Seroprotected Against 4 Strains of Influenza Disease(At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata(At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age(During the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination(During the entire study period (from Day 0 to Day 180))
- Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination(During the entire study period (from Day 0 to Day 180))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination(During the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Days With Solicited Local Symptoms After Vaccination(During the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination(During the 7-day follow-up period (Days 0-6) after vaccination)
- Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata(At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST))
- Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above(During the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 28-day follow-up period (Day 0-27) after vaccination)
- Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Day 180))
研究者
研究点 (34)
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