NCT00892775已完成2 期
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 6
- 主要终点
- Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.
研究概览
简要总结
This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.
A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
- •Free of obvious healthy problems 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first 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 each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each 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.
- •History of any neurologic disorders or seizures.
- •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
结局指标
主要结局
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.
时间窗: At 42-56 days after the first dose of study vaccine (Week 6)
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
次要结局
- Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.(At 42-56 days after the second dose of study vaccine (Week 18))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(Within 4 days after each vaccination (Days 0-3))
- Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms(Within 43 days (Days 0-42) after each vaccination)
- Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses(At 42-56 days after the first and second dose of study vaccine(s).)
- Number of Subjects Reporting Any, Grade 3 and Related Fever(Within 43 days (Days 0-42) after each vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)(Within 43 days (Days 86-128) after second vaccination dose)
- Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes(Within 43 days (Days 0-42) after each vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(From first study dose (Day 0) until study end (Week 18))
研究者
研究点 (6)
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