NCT02892812已完成1 期
A Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With LBVE013 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), LBVE014 (Pneumococcal 14-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Prevnar13 in Healthy Adults
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2016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
- 63
- 试验地点
- 1
- 主要终点
- Immediate reactions after vaccination
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) 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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult older than 19 years old and younger than 50 years old
- •A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form
排除标准
- •A subject who participated in other clinical studies within 3 months before screening
- •A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
- •A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
- •A subject who received immunoglobulin or blood-derived materials within 3 months before screening
- •A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
- •A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
- •A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
- •A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
- •A subject who was vaccinated with any pneumococcal vaccine before screening
- •A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)
结局指标
主要结局
Immediate reactions after vaccination
时间窗: Baseline(pre-vaccination) up to 30 minutes after vaccination
Solicited adverse events
时间窗: Baseline(pre-vaccination) up to 7 days after vaccination
Unsolicited adverse events
时间窗: Baseline(pre-vaccination) up to 4 weeks after vaccination
次要结局
- Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination(4 weeks after vaccination)
- Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination(4 weeks after vaccination)
- Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination(4 weeks after vaccination)
研究者
研究点 (1)
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