Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 598
- 主要终点
- Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
研究概览
简要总结
This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.
详细描述
This treatment has been approved for sale to the public.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subject is in good health based on medical history
- •Subject has no history of measles, mumps, rubella, chickenpox, or shingles
排除标准
- •Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
- •Subject has history of immune disorders
- •Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
- •Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
- •Subject has received a live vaccine within 30 days of first dose of study vaccine
- •Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
- •Subject has had a fever within 72 hours of study start
结局指标
主要结局
Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
时间窗: 6 weeks following first vaccination
Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer \< 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.
次要结局
未报告次要终点