Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 14
- 主要终点
- Antibody Titers Against Varicella Zoster Virus (VZV)
研究概览
简要总结
The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
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
- 11 Months 至 21 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A male or female between, and including, 11 and 21 months of age at the time of the first 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 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 within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines which can be administered up to eight days before each study vaccine dose.
- •Previous vaccination against varicella.
- •Known history of clinical varicella.
- •Known exposure to varicella within 30 days prior to study start.
- •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 vaccine(s), including systemic hypersensitivity to neomycin.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
- •Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C.
- •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
VARILRIX HSA-FREE GROUP
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
干预措施: Varilrix (inactivated varicella vaccine) (Biological)
VARILRIX GROUP
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
干预措施: Varilrix (inactivated varicella vaccine) (Biological)
结局指标
主要结局
Antibody Titers Against Varicella Zoster Virus (VZV)
时间窗: At 43-57 days after the first vaccine dose (Week 6)
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Antibody Concentrations Against Varicella Zoster Virus (VZV)
时间窗: At 43-57 days after the first vaccine dose (Week 6)
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\].
次要结局
- Number of Seroconverted Subjects for Varicella Antibodies(At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12))
- Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values(At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12))
- Antibody Titers Against Varicella Zoster Virus (VZV)(At 86-114 days after the second vaccine dose (Week 12))
- Antibody Concentrations Against Varicella Zoster Virus (VZV)(At 86-114 days after the second vaccine dose (Week 12))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period following each dose)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 43-day (Days 0-42) post-vaccination period following each dose)
- Number of Subjects With Any Unsolicited Adverse Event (AE)(Within the 43-day (Days 0-42) post-vaccination period following each dose)
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to study end (Day 86-114))