A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Percentage of Participants With at Least One Adverse Event (AE)
研究概览
简要总结
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
- •Male or female subject aged ≥18 to ≤65 years at the time of enrollment.
- •Negative urine pregnancy test.
排除标准
- •Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- •A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study.
- •Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- •Current chronic use of systemic antibiotics.
- •Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
- •Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- •Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.
- •History of microbiologically proven disease caused by Neisseria meningitidis.
研究组 & 干预措施
rLP2086
干预措施: rLP2086 (Biological)
结局指标
主要结局
Percentage of Participants With at Least One Adverse Event (AE)
时间窗: Vaccination 1 up to 1 month after Vaccination 3
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
时间窗: 1 month after vaccination 3
次要结局
- Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level(1 month after vaccination 3)
- Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ(1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3)
- Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined(1 month after vaccination 3)