A Phase IIIb, Open, Randomised, Multicentre, Primary Study in Healthy Children, to Establish the Non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA Vaccine (Administered at 9 and 15 Months of Age) Versus Priorix™ (9 Months of Age) and Priorix™ Co-administered With Varilrix™ at 15 Months of Age (Comparator) and Also to Evaluate the Non-inferiority of Priorix™ (9 Months of Age) and MeMuRu-OKA Vaccine (15 Months of Age) Versus the Comparator, All Administered Subcutaneously as Two-dose Primary Vaccination Course
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies
研究概览
简要总结
The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.
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
- 9 Months 至 10 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.
- •Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination.
- •Written informed consent obtained from the 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 other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine .
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product.
- •Previous vaccination against measles, mumps, rubella and varicella.
- •History of measles, mumps, rubella and/or varicella diseases.
- •Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Axillary temperature > 37.5°C (99.5°F) / Rectal temperature > 38°C (100.4°F).
- •Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
- •Presence of a susceptible high-risk person in the same household during the study period.
研究组 & 干预措施
Priorix-Tetra Group
Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
干预措施: GSK Biological's investigational MMRV vaccine 208136 (Biological)
Priorix/ Priorix-Tetra Group
Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
干预措施: GSK Biological's investigational MMRV vaccine 208136 (Biological)
Priorix/ Priorix-Tetra Group
Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
干预措施: Priorix™ (Biological)
Control Group
Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
干预措施: Priorix™ (Biological)
Control Group
Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
干预措施: Varilrix™ (Biological)
结局指标
主要结局
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies
时间窗: At 42 - 56 days after the second vaccination dose at week 30
Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
次要结局
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2))
- Number of Subjects With Serious Adverse Events (SAEs)(From the first study dose up to study end (Month 0 to Month 7.5 approximately))
- Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies(Approximately 42 to 56 days after the first vaccine dose at week 6)
- Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses(At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose)
- Number of Subjects Reporting Any, Grade 3 and Related Fever(During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2))
- Number of Subjects Reporting Any, Grade 3 and Related Rash(During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2))
- Number of Subjects Reporting Any Unsolicited Adverse Event(Within 43-day (Days 0-42) after the first and second vaccination dose)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2))