NCT01218308已完成3 期
Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine, GSK2282512A, (FLU Q-QIV) When Administered in Children
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,220
- 试验地点
- 13
- 主要终点
- Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.
研究概览
简要总结
This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine.
This study will also evaluate the immunogenicity and safety of the investigational vaccine.
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 8 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 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.
- •Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
- •Written 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.
- •Access to a consistent means of telephone contact
排除标准
- •Child in care.
- •Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.
- •Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at >=12 months of age.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 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-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.
- •Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; 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.
- •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 Reporting at Least One Confirmed Occurrence of Influenza A or B.
时间窗: From Day 14 to Day 180
To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.
次要结局
- Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains(On Day 0 and at least 6 months after first vaccination (Month 6))
- Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.(At least 6 months after first vaccination (Month 6))
- Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.(From Day 14 to Day 180)
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.(At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST])
- Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.(From Day 14 to Day 180)
- Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.(From Day 14 to Day 180)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST])
- Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.(At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST])
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST])
- Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.(During the 7-day (Days 0-6) follow-up period after any vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.(During the 7-day (Days 0-6) follow-up period after any vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.(During the 7-day (Days 0-6) follow-up period after any vaccination)
- Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.(At least 6 months after first vaccination (Month 6))
- Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.(At Day 0 and at least 6 months after first vaccination (Month 6))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 28-day (Days 0-27) follow-up period after vaccination)
- Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).(During the entire study period (Day 0 - Day 180))
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).(During the entire study period (Day 0 - Day 180))
- Number of Subjects With Any and Related Serious Adverse Events (SAEs).(During the entire study period (Day 0 - Day 180))
研究者
研究点 (13)
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