Immunogenicity and Safety Study of GlaxoSmithKline Biological's Live Attenuated Measles Mumps Rubella Varicella Vaccine (PriorixTetra™) When Co-administered With Conjugated Meningococcal C Vaccine (Meningitec®, Nuron Biotechs' Vaccine) in Healthy Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 716
- 试验地点
- 13
- 主要终点
- Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
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
- 13 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s)/ LAR of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the 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 the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
- •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-investigational product.
- •Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
- •History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
- •Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •Acute disease and/or fever at the time of enrollment.
- •Documented human immunodeficiency virus (HIV) positive subject.
- •Any contraindications as stated in the Summary of Product Characteristics.
- •Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
研究组 & 干预措施
Group A
Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
干预措施: PriorixTetra™ (Biological)
Group B
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
干预措施: PriorixTetra™ (Biological)
Group C
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
干预措施: PriorixTetra™ (Biological)
Group C
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
干预措施: Meningitec (Biological)
Group B
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
干预措施: Meningitec (Biological)
Group A
Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
干预措施: Meningitec (Biological)
结局指标
主要结局
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
时间窗: At 42 days after vaccination
Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.
Number of Seroprotected Subjects for rSBA-MenC Antibodies
时间窗: At 42 days after vaccination
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
次要结局
- Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses(At Day 42 after vaccination)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects Reporting Any, Localised and Generalised Rashes(Within the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects Reporting Fever Per Half Degree(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 43 days (Days 0-42) after each vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout study period (from Day 0 to approximately Month 4))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 15-day (Days 0-14) post-vaccination period)