A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Seroconversion rate for HI antibody after final injection
研究概览
简要总结
If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, 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 or control drug 1 time or 2 times.
详细描述
- Part 1 If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form, study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 time or 2 times.
- Part 2 If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, 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 or control drug 1 time or 2 times.
The investigator will evaluate the efficacy and safety of the test product while clinical trial.
Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety.
At visit1, blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, will re-visit and have the 2nd vaccination, 4~5 weeks after the 1st vaccination.
After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be collected. And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Healthy infants aged 6 month to 3 years.
- •Study subject was born at full term pregnancy(37 week)
- •Study subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form
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
- •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
- •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
研究组 & 干预措施
GC3110A
One injection: Day 0 Two injection: Day 0 and Day 28
干预措施: GC3110A (Biological)
GCFLU Pre-filled syringe inj.
One injection: Day 0 Two injection: Day 0 and Day 28
干预措施: GCFLU Pre-filled syringe inj. (Biological)
结局指标
主要结局
Seroconversion rate for HI antibody after final injection
时间窗: Post-vaccination (Day 28 or 56)
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)
Seroprotection rate for HI antibody after final injection
时间窗: Post-vaccination (Day 28 or 56)
次要结局
- GMR(Post-vaccination (Day 28 or 56))
- GMT(Post-vaccination (Day 28 or 56))