A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,249
- 试验地点
- 59
- 主要终点
- Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
研究概览
简要总结
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers
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
- None
入排标准
- 年龄范围
- 365 Days 至 394 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
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 to enrollment.
研究组 & 干预措施
12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
干预措施: 1a - rMenB+OMV NZ and routine vaccines (Biological)
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
干预措施: 1b - rMenB+OMV NZ and routine vaccines (Biological)
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
干预措施: 2a - Routine and rMenB+OMV NZ vaccines (Biological)
12M12B14B (2b)
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
干预措施: 2b - rMenB+OMV NZ and routine vaccines (Biological)
12B12M (3a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
干预措施: 3a - rMenB+OMV NZ and routine vaccines (Biological)
12B13M (3b)
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
干预措施: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations (Biological)
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
干预措施: 4a- rMenB+OMV NZ and routine vaccines (Biological)
12B13M_C (4b)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
干预措施: 4b - rMenB+OMV NZ and routine vaccines (Biological)
结局指标
主要结局
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
时间窗: one month after the booster (fourth) dose
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
次要结局
- Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination(From day 1 to day 7 after each rMenB+MV NZ vaccination.)
- Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)(one month after booster (fourth) dose vaccination and pre-fourth dose vaccination)
- SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule(One month after the second dose.)
- Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination(one month after booster (fourth) dose)
- ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers(One month after the first dose and one month after the second dose.)
- Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age(From day 1 to day 7 after each rMenB+OMV NZ vaccination.)
- Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)(one month after third vaccination and pre dose fourth (booster) vaccination)
- Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)(One month post vaccination and pe-booster (fourth) dose vaccination)
- Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule(One month after the second dose.)
- Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age(From day 8 to day 28 after MMRV vaccination.)
- The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination(one month after booster (fourth) vaccination.)
- ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months(One month after the fourth (booster) dose.)
- Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months(One month after the fourth (booster) dose.)
- Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age(From day 1 to day 7 after MMRV vaccination.)