Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 14
- 主要终点
- Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
研究概览
简要总结
This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.
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
- 11 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- •Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
- •Previous vaccination against measles, mumps, rubella and/or varicella.
- •History of measles, mumps, rubella and/or varicella/zoster diseases.
- •Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
- •Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
- •Residence in the same household as a high risk person e.g.:
- •New-born infants (0-4 weeks of age)
- •Pregnant women who have a negative history of chickenpox
- •Persons with known immunodeficiency
研究组 & 干预措施
PRIORIX-TETRA GROUP
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
干预措施: Priorix-Tetra® (Biological)
PRIORIX + VARILRIX GROUP
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
干预措施: PriorixTM (Biological)
PRIORIX + VARILRIX GROUP
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
干预措施: VarilrixTM (Biological)
结局指标
主要结局
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
时间窗: At 42 days post-vaccination
Seroconversion was defined as the appearance of antibodies \[i.e. titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative \[i.e. titer below (\<) cut-off value\] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.
次要结局
- Antibody Concentrations Against Rubella(At 42-days post-vaccination)
- Antibody Concentrations Against Mumps(At 42-days post-vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Antibody Concentrations Against Measles(At 42-days post-vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 43-day (Days 0-42) post-vaccination period)
- Antibody Titers Against Varicela Viruses(At 42-days post-vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Day 43 or Day 57))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 43-day (Days 0-42) post-vaccination period)