A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.
研究概览
简要总结
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Months 至 62 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects)
- •Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)
排除标准
- •Previous ascertained or suspected disease caused by N. meningitidis
- •History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
- •Any serious chronic or progressive disease
- •Known or suspected impairment/alteration of the immune system
- •Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
研究组 & 干预措施
5rMenB
Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.
干预措施: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (Biological)
5rMenB+OMV NZ
Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.
干预措施: Meningococcal (group B) multicomponent recombinant adsorbed vaccine. (Biological)
3rMenB
Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine without OMV (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.
干预措施: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (Biological)
3rMenB+OMV NZ
Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.
干预措施: Meningococcal (group B) multicomponent recombinant adsorbed vaccine. (Biological)
Naive_4042
Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 40 and 42 months of age in the present study.
干预措施: Meningococcal (group B) multicomponent recombinant adsorbed vaccine. (Biological)
Naive_6062
Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 60 and 62 months of age in the present study.
干预措施: Meningococcal (group B) multicomponent recombinant adsorbed vaccine. (Biological)
结局指标
主要结局
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.
时间窗: 28 months after last vaccination; Baseline for Naïve
Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.
时间窗: 28 months after last vaccination; baseline for naïve
The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.
时间窗: Day 1-7 after booster vaccination
The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.
次要结局
- Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.(1 month post - booster/ -dose 1 for Naïve)
- Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.(1 month post vaccination)
- Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.(1 month post -vaccine dose two)
- Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.(1 month post vaccine dose two)
- Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.(1 month post- booster/ dose 1 for Naïve)
- Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.(1 month post vaccination)
- Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.(1 month post vaccine dose two)
- Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.(28 months after vaccination; Baseline for Naïve)
- Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.(28 months after vaccination; baseline for naïve)
- Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.(1 month post- booster/ dose 1 for Naïve)
- Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.(1 month post vaccination)
- Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.(18-20 months after last Men B vaccine; baseline for naïve_6062)
- Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.(28 months after last Men B vaccination; baseline for naïve_4042 group)
- Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.(1 month post booster; 1 month post dose for naïve_4042 group)
- Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.(1 month post vaccine dose 2)
- Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.(18-20 months after last Men B vaccine; baseline for naïve_6062)
- Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.(28 months after last Men B vaccination; Baseline for Naïve_4042 group)
- Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.(1 month after each booster/ vaccine dose)
- Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.(18-20 months after last Men B vaccine; baseline for naïve_6062)
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.(Day 1-7 after any vaccination)