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临床试验/NCT02541253
NCT02541253已完成3 期

An Open-label(Part1), Single Arm(Part1), Randomized(Part2), Double-blind(Part2), Active-controlled(Part2), Phase III Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children

Green Cross Corporation12 个研究点 分布在 1 个国家目标入组 543 人开始时间: 2015年9月最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
543
试验地点
12
主要终点
The percentage of study subjects achieving seroconversion* for HI antibody(seroconversion rate) The percentage of study subjects achieving a post-vaccination HI antibody titer≥1:40 (seroprotection rate)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age.
  2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2 times according to age as below;
  • 6 m ~ 3 years
  • 3 years ~ 9 years
  • 9 years ~ 19 years

详细描述

  1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age.

The safety data collected during part A will be reviewed by DSMB to evaluate the solicited adverse events for 7 days after each vaccination.

However, if no toxicity higher than grade 3 according to FDA guidance the study was allowed to proceed to Part 2 without DSMB review.

Efficacy and safety assessment methods, and visiting schedule will be the same as Part 2. 2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2 times according to age as below;

  • 6 m ~ 3 years
  • 3 years ~ 9 years
  • 9 years ~ 19 years The investigator will evaluate the efficacy and safety of the test product while clinical trial.

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, Investigator)

入排标准

年龄范围
6 Months 至 19 Years（Child, Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy infants and adolescents aged 6 month to 19 years
  • •study Subject was born at full term pregnancy(37 weeks)
  • •study Subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form (less than 7 years of age, written informed consent by study subject's legal guardians)

排除标准

  • •Those with a history of allergic reaction to eggs or chicken, the vaccine components
  • •Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination
  • •Those with immunologic impairment including immune deficiency disorders or family history about it.
  • •Those with a history of Guillain-Barre syndrome
  • •Those with a history of Down's syndrome or cytogenetic disorders
  • •Those who would be ineligible to participate the study as follows: serious chronic disease (cardiovascular system disease; excluding controlled hypertension and respiratory system disease; including respiratory failure, metabolic disease, renal dysfunction, hemoglobinopathy, etc)
  • •Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy
  • •Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug
  • •Those who had been vaccinated with another vaccine within 28 days prior to the dosing of study drug or had a scheduled vaccination during the clinical trial period
  • •Those who had received an immunosuppressant, immunity-modifying drug within 3 months prior to the dosing of study drug - (1) Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc., (2) Those receiving high dose of corticosteroid(15mg/day of prednisolone is acceptable, but study subject used consistently 2mg/kg more than 14days is considered a high dose, so excluded in this clinical trial. However, inhalated, intra nasal and topical administration is acceptable regardless of dose.
  • •Those who had received immunoglobulin or a blood-derived product within 3 months prior to the dosing of study drug or is scheduled to receive those products during the study period
  • •Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug
  • •study Subject who had participated in other clinical trial within 28 days prior to the study vaccination
  • •Those whose clinically significant medical or psychiatric condition at the discretion of the investigator that would be ineligible to participate the study

结局指标

主要结局

The percentage of study subjects achieving seroconversion* for HI antibody(seroconversion rate) The percentage of study subjects achieving a post-vaccination HI antibody titer≥1:40 (seroprotection rate)

时间窗: Post-vaccination (Day 28)

the percentage of study subjects with a pre-vaccination (Day 0) HI titer\<1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2)

次要结局

  • GMT(Post-vaccination (Day 28))
  • GMR(Post-vaccination (Day 28))
  • The solicited adverse events (7 days after vaccination)(Post-vaccination (Day 7))
  • The unsolicited adverse events (28 days after vaccination)(Post-vaccination (Day 28))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (12)

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