NCT01393951已完成1 期
Study for Immunogenicity and Safety of ASP7374 for Subcutaneous and Intramuscular Vaccination in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Immunogenicity: HI antibody titer
研究概览
简要总结
This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.
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
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight: Female: ≥40.0 kg, <70.0 kg, Male: ≥50.0 kg, <80.0 kg
- •BMI: ≥17.6, <26.4
- •Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained
排除标准
- •Scheduled to receive another vaccine during study participation period
- •Received influenza vaccine within 180 days prior to the study
- •Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
- •Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
- •Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
- •Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
研究组 & 干预措施
sc dose 2
Experimental
subcutaneous vaccination of ASP7374 dose-2
干预措施: ASP7374 (Biological)
im dose 3
Experimental
intramuscular (im) vaccination of ASP7374 dose-3
干预措施: ASP7374 (Biological)
sc dose 1
Experimental
subcutaneous (sc) vaccination of ASP7374 dose-1
干预措施: ASP7374 (Biological)
结局指标
主要结局
Immunogenicity: HI antibody titer
时间窗: Day 29
Safety: Incidence of Adverse events, vital signs and laboratory tests
时间窗: 28 days post-vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate Intramuscular ASP7374VaccineInfluenzaNCT01961960UMN Pharma Inc.55
已完成
2 期
Clinical Study for the Treatment of Adhesive Capsulitis of the ShoulderAdhesive CapsulitisFrozen ShoulderNCT02006719Endo Pharmaceuticals322
已完成
1 期
An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral DensityOsteopeniaNCT01101048Amgen74
已完成
不适用
A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a BoosterCOVID-19SARS-CoV-2 InfectionNCT06381843WestVac Biopharma Co., Ltd.120
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy ParticipantsChronic Graft-versus-host Disease (cGVHD)NCT05873907Amgen64