NCT01439360已完成3 期
An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-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
- 12,046
- 试验地点
- 104
- 主要终点
- Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
- •Written informed consent obtained from the parent(s) /LAR(s) of the subject.
- •Subjects in stable health as determined by medical history and clinical examination before entering into the study.
排除标准
- •Participation in a previous FLU-D-QIV-004 study (115345) cohort.
- •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 influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
- •Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
- •Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
- •Any contraindication to intramuscular injection.
- •Acute disease and/or fever at the time of enrolment.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
- •Additional criteria for children ≥ 12 months of age:
- •Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.
- •* For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
- •Any history of hepatitis A or varicella diseases.
- •Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
- •Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
研究组 & 干预措施
D-QIV
Experimental
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
干预措施: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
干预措施: Varivax/ProVarivax (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
干预措施: Varilrix (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
干预措施: Prevenar 13 (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
干预措施: Havrix Junior (Biological)
结局指标
主要结局
Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
时间窗: During the surveillance period (approximately 6 to 8 months)
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
时间窗: During the surveillance period (approximately 6 to 8 months)
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
次要结局
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.(At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.(During the surveillance period (approximately 6 to 8 months))
- Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)(At Day 0 and Day 28/56)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).(During the entire study period (approximately 6- 8 months per subject))
- Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.(At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months))
- Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)(At Days 0 and 28/56)
- Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)(At Day 28/56 (POST))
- Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).(At Day 28/56 (POST))
- Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)(At Day 0 and Day 28/56)
- Duration of Solicited Local Symptoms(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Duration of Solicited General Symptoms(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 28-day (Days 0-27) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)(During the entire study period (approximately 6- 8 months per subject))
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).(During the entire study period (approximately 6- 8 months per subject))
研究者
研究点 (104)
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