NCT03467984已完成2 期
A Single-blind, Multi-center, Randomized, Active-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Immunogenicity of Intramuscular Three Injections With LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants
LG Chem1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2018年5月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
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
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
- •The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
- •Signed informed consent by subject's parents or LAR(Legally authorized representative)
排除标准
- •Previously received any pneumococcal vaccine
- •Receipt of immunoglobulin or blood-derived product before the study
- •Known or suspected immune disorder, or received immunosuppressive therapy
- •Known major congenital malformation or serious chronic disorder
- •Participation in another interventional trial
研究组 & 干预措施
Prevnar13
Active Comparator
Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age
干预措施: Prevnar13 (Biological)
LBVE
Experimental
Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age
干预措施: LBVE (Biological)
结局指标
主要结局
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
时间窗: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
时间窗: 4 weeks after 3rd(last) vaccination
次要结局
- Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer(4 weeks after 3rd(last) vaccination)
- Unsolicited adverse events(Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination)
- Solicited adverse events(Baseline(pre-vaccination) up to 7 days after each vaccination)
- Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios(4 weeks after 3rd(last) vaccination)
研究者
研究点 (1)
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