A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,596
- 试验地点
- 190
- 主要终点
- Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
研究概览
简要总结
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject aged >=10 and <19 years at the time of enrollment.
- •Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- •Negative urine pregnancy test for all female subjects.
排除标准
- •Previous vaccination with any meningococcal serogroup B vaccine.
- •Subjects who have received prior HAV vaccination.
- •Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
- •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, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States 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 vaccines, drugs, 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.
结局指标
主要结局
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
时间窗: One month after third bivalent rLP2086 vaccination
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine
时间窗: One month after third bivalent rLP2086 vaccination
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
时间窗: Within 7 Days after first vaccination
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
时间窗: Within 7 Days after second vaccination
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
时间窗: Within 7 Days after third vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
时间窗: Within 7 Days after first vaccination
Here, N signifies participants with known values reporting specific characteristic.
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
时间窗: Within 7 Days after second vaccination
Here, N signifies participants with known values reporting specific characteristic.
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
时间窗: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
时间窗: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
时间窗: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
时间窗: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period
时间窗: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
时间窗: Within 30 days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
时间窗: Within 7 Days after third vaccination
Here, N signifies participants with known values reporting specific characteristic.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
时间窗: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
时间窗: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
时间窗: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
时间窗: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
时间窗: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
时间窗: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
时间窗: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
时间窗: Within 30 Days After any Vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
时间窗: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
时间窗: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
时间窗: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase
时间窗: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
时间窗: 30 days after second vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
时间窗: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
时间窗: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
时间窗: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination
时间窗: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
时间窗: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase
时间窗: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination
时间窗: Within 30 Days after any vaccination
Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination
时间窗: Within 30 minutes after second vaccination
Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination
时间窗: Within 30 minutes after third vaccination
Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase
时间窗: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination
时间窗: Within 30 minutes after first vaccination
次要结局
- hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination(Before vaccination (Vac) 1, 1 Month after Vac 2)
- Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1(Before first vaccination, 1 month after third vaccination (Vac))
- Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1(Before first vaccination, 1 month after third vaccination)
- Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1(One month after second Bivalent rLP2086 vaccination)
- Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination(Before Vaccination (Vac) 1, 1 Month after Vac 2, 3)
- hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1(Before first vaccination, 1 month after third vaccination)
- Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination(One month after second, third vaccination)
- Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination(Before Vaccination (Vac) 1, 1 Month after Vac 2, 3)
- Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination(One month after third bivalent rLP2086 vaccination)
- Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1(Before vaccination 1, 1 Month after Vaccination 2)
- Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination(One month after third bivalent rLP2086 vaccination (Vac))