A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal Group B Vaccine, in Healthy Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,063
- 试验地点
- 33
- 主要终点
- Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.
研究概览
简要总结
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
- •Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
- •Female subjects of childbearing potential must have a negative urine preganancy test.
排除标准
- •Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
- •Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
研究组 & 干预措施
rMenB_0_2 Group
Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
干预措施: Bexsero (Biological)
rMenB_0_2 Group
Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
干预措施: Saline Placebo (Other)
rMenB_0_2 Group
Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
干预措施: Havrix (Biological)
ABCWY_ 0_2 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
干预措施: Saline Placebo (Other)
ABCWY_ 0_2 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
干预措施: Havrix (Biological)
ABCWY_ 0_2 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.
干预措施: MenABCWY (Biological)
ABCWY_0_1 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
干预措施: Saline Placebo (Other)
ABCWY_0_1 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
干预措施: Havrix (Biological)
ABCWY_0_1 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.
干预措施: MenABCWY (Biological)
ABCWY_0_6 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
干预措施: Saline Placebo (Other)
ABCWY_0_6 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
干预措施: Havrix (Biological)
ABCWY_0_6 Group
Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.
干预措施: MenABCWY (Biological)
ABCWY_0_11 Group
Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
干预措施: Saline Placebo (Other)
ABCWY_0_11 Group
Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
干预措施: Havrix (Biological)
ABCWY_0_11 Group
Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.
干预措施: MenABCWY (Biological)
ABCWY_0_2_6 Group
Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
干预措施: Havrix (Biological)
ABCWY_0_2_6 Group
Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
干预措施: MenABCWY (Biological)
结局指标
主要结局
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.
时间窗: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)
The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB_0_2 and ABCWY_ 0_2 Groups.
次要结局
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule.(At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group))
- hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13)
- Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule.(At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7))
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.(At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3))
- hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule.(At 1 month after last vaccination (Month 7))
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule.(At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group))
- Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule.(At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group))
- Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule.(At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group))
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination.(Within 30 minutes after vaccination)
- Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules.(At Month 0, Month 2, Month 3, Month 7 and Month 13.)
- Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules.(At Month 2, Month 3, Month 7 and Month 13)
- Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination.(Day 1 through Day 30 after any vaccination)
- The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains.(From Month 0 to Month 13)
- Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.(At Day 1 (6 hours) to Day 7 after vaccination)
- Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal(During the entire study period (Month 0 to Month 13))
- Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination.(Within 30 minutes after vaccination)