临床试验/NCT03076385

NCT03076385已完成1 期

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects

ModernaTX, Inc.1 个研究点分布在 1 个国家目标入组 201 人开始时间: 2015年12月最近更新: 2022年4月22日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: ModernaTX, Inc.
入组人数: 201
试验地点: 1
主要终点: Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug

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

This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug

时间窗: Through 13 months of study participation

次要结局

Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples(Through 13 months of study participation)
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples(Through 13 months of study participation)

研究者

发起方

ModernaTX, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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