NCT03549208Unknown1 期
Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults
LG Chem0 个研究点目标入组 60 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- Solicited adverse events
研究概览
简要总结
phase-1 study pneumococcal conjugate vaccine study in healthy adults
详细描述
A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) 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)
研究组 & 干预措施
Prevnar13
Active Comparator
Multivalent pneumococcal conjugate vaccine Prevnar13
干预措施: Prevnar13 (Biological)
LBVE01
Experimental
Multivalent pneumococcal conjugate vaccine
干预措施: LBVE01 (Biological)
LBVE02
Experimental
Multivalent pneumococcal conjugate vaccine
干预措施: LBVE02 (Biological)
结局指标
主要结局
Solicited adverse events
时间窗: Baseline(pre-vaccination) up to 7 days after
Solicited adverse events
Unsolicited adverse events
时间窗: Baseline(pre-vaccination) up to 4 weeks after vaccination
Unsolicited adverse events
Immediate reactions after vaccination
时间窗: Baseline(pre-vaccination) up to 30 minutes after vaccination
Immediate reactions after vaccination
次要结局
- Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 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)
- Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination(4 weeks After Vaccination)
研究者
相似试验
已完成
1 期
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)Pneumococcal ImmunizationNCT06698198Sanofi Pasteur, a Sanofi Company175
已完成
1 期
Phase 1 Study of a pPCV in Healthy Japanese AdultsJPRN-jRCT2071200094Tanaka Yoshiyuki102
进行中（未招募）
不适用
The role of under-fives in pneumococcal transmission to newborn babies within householdsISRCTN10912262iverpool School of Tropical Medicine2,588
Unknown
1 期
Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 MonthsPneumonia, PneumococcalNCT04108845Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd80
已完成
1 期
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate VaccinePneumococcal Infectious DiseaseNCT06183216Sinovac Research and Development Co., Ltd.140