A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 538
- 试验地点
- 27
- 主要终点
- Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
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
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
- •Negative urine pregnancy test for all female subjects.
- •Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
排除标准
- •History of any invasive meningococcal disease.
- •A previous anaphylactic or severe vaccine-associated adverse reaction.
- •Any clinically significant chronic disease.
- •A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
- •Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
研究组 & 干预措施
4
normal saline (placebo)
干预措施: normal saline (placebo) (Other)
1
dose level 1 rLP2086 vaccine
干预措施: meningococcal B rLP2086 vaccine. (Biological)
2
dose level 2 rLP2086 vaccine
干预措施: meningococcal B rLP2086 vaccine. (Biological)
3
dose level 3 rLP2086 vaccine
干预措施: meningococcal B rLP2086 vaccine. (Biological)
结局指标
主要结局
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
时间窗: Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
时间窗: Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
时间窗: Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
时间窗: 6 month after vaccination 3 up to 48 months
次要结局
- Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level(1 month before vaccination 1, 1 month after vaccination 2, 3)