An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,800
- 主要终点
- Participants With 1 or More Injection-Site Adverse Experiences
研究概览
简要总结
Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.
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
- 12 Months 至 17 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster
- •No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM)
排除标准
- •Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination
- •History of allergy to any vaccine component
- •History of seizure disorder
- •Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy
- •Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections
- •Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.
研究组 & 干预措施
1
Arm 1: vaccine
干预措施: VAQTA® (Biological)
2
Arm 2: Active comparator
干预措施: VAQTA® (Biological)
2
Arm 2: Active comparator
干预措施: ProQuad (Biological)
结局指标
主要结局
Participants With 1 or More Injection-Site Adverse Experiences
时间窗: Days 1 to 14 after any vaccination
Participants With Mumps-Like Symptoms After First Vaccination
时间窗: Days 1 to 28 After First Vaccination
Participants With Varicella/Zoster-Like Rash After First Vaccination
时间窗: Days 1 to 28 After First Vaccination
Participants With Elevated Temperature (>=102.2F/39.0C)
时间窗: Days 1 to 5 After Any Vaccination
Participants With Measles-Like Rash After First Vaccination
时间窗: Days 1 to 28 After First Vaccination
Participants With Rubella-Like Rash After First Vaccination
时间窗: Days 1 to 28 After First Vaccination
Participants With Rubella-Like Rash After Second Vaccination
时间窗: Days 1 to 28 After Second Vaccination
Participants With Mumps-Like Symptoms After Second Vaccination
时间窗: Days 1 to 28 After Second Vaccination
Participants With Varicella/Zoster-Like Rash After Second Vaccination
时间窗: Days 1 to 28 After Second Vaccination
Participants With 1 or More Serious Vaccine-Related Adverse Experiences
时间窗: Days 1 to 14 after any vaccination
Participants With Measles-Like Rash After Second Vaccination
时间窗: Days 1 to 28 After Second Vaccination
次要结局
- Participants With 1 or More Systemic Adverse Experiences(Days 1 to 14 After Any Vaccination)