NCT06125717已完成1 期
A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
Vaxess Technologies6 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年7月2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
- 45
- 试验地点
- 6
- 主要终点
- To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
研究概览
简要总结
A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 - 39 years inclusive
- •Provide written informed consent to participate
- •Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- •o As determined by medical history, physical exam, laboratory screening
- •Body Mass Index 18-35 kg/m2, inclusive, at screening
排除标准
- •Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe.
- •Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
- •Impaired immune responsiveness (of any cause), including diabetes mellitus.
- •Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination.
- •Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study.
- •Diagnosed influenza infection in the previous 24 months prior to screening.
- •Diagnosed COVID infection via medical personnel or at home test within the past 60 days prior to screening
- •Allergy to influenza vaccine or components, or history of severe local or systemic reaction to any vaccination.
- •History of anaphylactic type reaction to injected vaccines
- •History of or current allergy to latex
- •History of Guillain-Barré Syndrome.
- •Positive test result for hepatitis B surface antigen (HBsAg,), hepatitis C virus antibody (HBcAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
- •History of chronic obstructive pulmonary disease or history of other lung disease.
- •History of severe allergic reactions to eggs.
结局指标
主要结局
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
时间窗: 180 Days
次要结局
未报告次要终点
研究者
研究点 (6)
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