NCT02111070已完成1 期
Open-label, Phase I Clinical Trial to Assess the Immunogenicity and Safety of the 'IL-YANG Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects
Il-Yang Pharm. Co., Ltd.2 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Solicited local & general AE, Unsolicited AE
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single intramuscular injection
详细描述
This was an open-label study. Subjects providing voluntary written informed consent underwent protocol-specific assessments and tests within 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria and were considered eligible were sequentially enrolled in the study.
Subjects enrolled in the study received 0.5ml of the study vaccine as an intramuscular injection in the deltoid muscle, and returned to the clinic every day for the first 3 days. On Day 14 post-vaccination, subjects underwent the safety assessments. On Day 28 post-vaccination, subjects returned for safety and immunogenicity assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males between 20 and 55 years of age at screening
- •Body weight of ≥ 55kg and within ±20% of ideal body weight (ideal body weight = (height cm - 100) X 0.9) at screening
- •Subjects with no congenital or chronic disease who were considered suitable for the study after screening assessments (investigator's opinion, medical history, physical examination, laboratory test, chest X-ray, and ECG) conducted within 28 days prior to vaccination
- •Subjects who were given, and fully understood, the information about the study, made a voluntary decision, and provided written informed consent, to participate in the study and comply with all applicable study requirements
排除标准
- •Subjects with pre-vaccination HI antibody titer ≥ 1:40
- •Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL (via ELISA screening or medical history taking)
- •Subjects who have concurrent or a past history of immune deficiency disease
- •Subject who had participated in blood donation within 1 week prior to vaccination, or are planning to participate in blood donation from Day 1 until Month 7 post-vaccination
- •Subject with a history of Guillain-Barre syndrome
- •Subject with hemophilia, thrombocytopenia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
- •Subjects who have concurrent or a past history of, malignant tumor of internal organ or blood vessels or skin metastasis
- •Subjects with known allergy to a drug, food or latex, who had a history of anaphylaxis
- •Subjects who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the study vaccine or symptoms of suspected acute disease within 14 days prior to administration of the study vaccine
- •Subjects who received another experimental drug or vaccine within 28 days before administration of the study vaccine or are planning to receive another experimental drug or vaccine during the study.
- •Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are expecting to be treated with immunoglobulin or blood-derived products during the study
- •Subjects who had received, or are scheduled to receive, systemic immunosuppressive therapy, radiation therapy or high-dose steroid therapy within the last 6 months prior to administration of the study
- •Subjects who had received, or are expected to receive, the medications listed below: Within 28 days prior to administration of the study vaccine: Oriental herbal medicine, Within 14 days prior to administration of the study vaccine: Prescription drugs, Within 7 days prior to administration of the study vaccine: Over-the-counter medicine (including vitamin/mineral supplements)
- •Subjects with a history of, or suspected, drug abuse (amphetamine, barbiturates, opioids, benzodiazepines, etc.) based on subject interview and physical examination.
- •Subjects with excessive consumption of caffeine (> 5 cups/day) and alcohol (>3 units/day, 1unit= 10g or 12.5ml of pure alcohol), and excessive smoking (>10 cigarettes/day)
- •Subject with a known allergy to eggs, chicken, or any components of the study vaccine
- •Subjects who in the investigator's opinion, may not be suitable for vaccination or who may interfere with the objective assessment of the study outcomes.
结局指标
主要结局
Solicited local & general AE, Unsolicited AE
时间窗: up to Day28(+7)
Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia
Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine
时间窗: Day28(+7)
Seroprotection: HI antibody titer ≥ 1:40 28 days after the administration of the study vaccine
次要结局
- Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a minimum four-fold rise in post-vaccination (vaccination + 28 days) HI antibody titer(Day28(+7))
- GMT of HI antibody titer before vaccination and after vaccination(Day28(+7))
- Vital signs measurements, physical examination findings, ECG results, and laboratory measurements (hematology, biochemistry and urinalysis)(Day28(+7))
研究者
研究点 (2)
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