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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,220
- 试验地点
- 12
- 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.
研究组 & 干预措施
FluLaval® Quadrivalent Group
Experimental
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
干预措施: FluLaval® Quadrivalent (Biological)
Havrix Group
Active Comparator
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
干预措施: Havrix™ (Biological)
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 (12)
Loading locations...
相似试验
已完成
4 期
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in AdultsInfluenzaNCT00363870GlaxoSmithKline7,632
已完成
3 期
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in ChildrenInfluenzaNCT01198756GlaxoSmithKline3,109
已完成
3 期
Study of Quadrivalent Influenza Vaccine Among ChildrenInfluenzaNCT01240746Sanofi Pasteur, a Sanofi Company4,363
已完成
2 期
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of AgeInfluenzaNCT01974895GlaxoSmithKline316
已完成
3 期
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in AdultsInfluenzaNCT01196975GlaxoSmithKline1,707