EUCTR2004-005263-19-DE进行中（未招募）不适用
A phase III, blinded, randomised, controlled study to evaluate the immunogenicity and safety of three production lots of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella (MeMuRu-OKA) candidate vaccine given on a two-dose schedule to healthy children in their second year of life. - MeMuRu-OKA 044
GSK Biologicals0 个研究点目标入组 944 人开始时间: 2005年2月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 944
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •? Male or female subjects between 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.
- •? Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •? Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to the first vaccination until 42-56 days after each vaccination (Week 12).
- •? 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/zoster within 30 days prior to the start of the study.
- •? 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.
- •? Major congenital defects or serious chronic illness.
- •? History of any neurologic disorders or seizures.
- •? Residence in the same household as the following persons:
- •? New-born infants (0-4 weeks of age).
- •? Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
- •? Persons with known immunodeficiency.
- •? Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C / rectal temperature <38°C.
- •? Rectal temperature =38.0ºC or axillary temperature =37.5ºC at the time of vaccination.
- •? Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
研究者
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