A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,551
- 主要终点
- Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
研究概览
简要总结
A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.
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
- •Immune globulin or any blood product administered in the past 3 months
研究组 & 干预措施
1
ProQuad (low dose)
干预措施: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological)
2
ProQuad (middle dose)
干预措施: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological)
3
ProQuad (high dose)
干预措施: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological)
4
M-M-R II + PUVV
干预措施: Comparator: M-M-R II (Biological)
4
M-M-R II + PUVV
干预措施: Comparator: PUVV (Biological)
结局指标
主要结局
Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
时间窗: 6 weeks postvaccination
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
次要结局
- Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL(6 weeks postvaccination)
- Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL(6 weeks Postvaccination)
- Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)(6 weeks Postvaccination)
- Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL(6 weeks Postvaccination)
- Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)(6 weeks postvaccination)
- Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)(6 weeks Postvaccination Visit 1 or Visit 2)
- Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)(6 weeks Postvaccination)
- Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)(6 weeks Postvaccination)