A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 751
- 试验地点
- 42
- 主要终点
- Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.
研究概览
简要总结
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
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
- 55 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.
排除标准
- •Serious, acute, or chronic illnesses are reasons for exclusion.
研究组 & 干预措施
MenACWY3
Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
干预措施: MenACWY-CRM (Biological)
MenACWY3
Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
干预措施: Routine Vaccines (Biological)
MenACWY4
All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
干预措施: Routine Vaccines (Biological)
Routine Vaccines
Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.
干预措施: Routine Vaccines (Biological)
MenACWY4
All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
干预措施: MenACWY-CRM (Biological)
结局指标
主要结局
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.
时间窗: 13 months of age
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.
时间窗: 13 months of age
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
次要结局
- GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.(13 months of age)
- Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.(12 months of age.)
- Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.(13 months of age.)
- Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.(Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age)
- Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.(12 months of age)
- Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.(7 months of age.)
- Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.(Within 7 days)
- Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.(Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.)
- Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.(Day 1 through Day 7)
- Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.(13 months of age)
- Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.(13 months of age)