A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5,715
- 试验地点
- 163
- 主要终点
- Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
研究概览
简要总结
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 10 to 25 years.
排除标准
- •Previous vaccination with Hepatitis A virus vaccine
- •Previous vaccination with investigational meningococcal B vaccine
- •History of culture-proven N. meningitidis serogroup B disease
- •Any neuroinflammatory or autoimmune condition
- •Any immune defect that would prevent an effective response to the study vaccine
研究组 & 干预措施
control
The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
干预措施: control (Biological)
结局指标
主要结局
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
时间窗: Vaccination 1 up to 6 months after Vaccination 3
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
时间窗: Within 30 days after Vaccination 1
A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
时间窗: Within 30 days after Vaccination 2
A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
时间窗: Within 30 days after Vaccination 3
A medically attended AE was defined as a non-serious AE that required medical attention.
次要结局
- Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination(Within 30 minutes after Vaccination 1, 2, 3)
- Number of Days Participant Missed School or Work Due to Adverse Events (AEs)(Vaccination 1 up to 1 month after Vaccination 3)
- Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods(Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3))
- Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods(Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3))
- Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods(Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3))
- Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods(Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3))