Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,927
- 主要终点
- Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
研究概览
简要总结
This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health
- •Negative clinical history of measles, mumps, rubella, varicella, and zoster
排除标准
- •Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
- •Any immune impairment or deficiency
- •Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
- •Vaccination with an inactive vaccine with in the past 14 days
- •Vaccination with a live vaccine within the past 30 days
结局指标
主要结局
Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
时间窗: 6 weeks Postvaccination
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \< 1.25 gpELISA units/mL at Baseline
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
时间窗: 6 weeks Postvaccination
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 120 mIU/mL) to Measles at Baseline
Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
时间窗: 6 weeks Postvaccination
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 IU/mL) to Rubella at Baseline
Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Mumps.
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
时间窗: 6 weeks Postvaccination
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 Ab units/mL) to Mumps at Baseline
Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Measles.
Number of Participants With Serious Vaccine-related CAEs
时间窗: 6 weeks Postvaccination
Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
次要结局
未报告次要终点