An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,388
- 主要终点
- Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
研究概览
简要总结
Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life.
Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 22 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject of either gender,
- •Age from 12 to 22 months,
- •Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
- •Informed consent form signed by the parent(s) or by legal representative
- •Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures
排除标准
- •Recent (≤ 3 days) history of febrile illness
- •Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
- •Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
- •Prior known sensitivity/allergy to any component of the vaccine
- •Severe chronic disease,
- •Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
- •Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
- •Humoral or cellular immunodeficiency,
- •Current immunosuppressive therapy
- •Family history of congenital or hereditary immunodeficiency
- •Hereditary problems of fructose intolerance
- •Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- •Known active tuberculosis
- •Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
- •Receipt of immunoglobulins or blood-derived products in the past 150 days
- •Receipt of an inactivated vaccine in the past 14 days
- •Receipt of a live vaccine in the past 28 days
- •Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
- •Participation in another clinical study in the past 30 days
研究组 & 干预措施
ProQuad®
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
干预措施: ProQuad® (Biological)
结局指标
主要结局
Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
时间窗: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.
Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
时间窗: Up to Day 46 (for 4 days following ProQuad® Dose 2)
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2
时间窗: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.
Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2
时间窗: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
次要结局
- Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1(From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1))
- Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1(Up to Day 28 (28 days after ProQuad® Dose 1))
- Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1(Up to Day 28 (28 days after ProQuad® Dose 1))
- Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1(Up to Day 28 (28 days after ProQuad® Dose 1))