EUCTR2004-005123-18-FI进行中（未招募）1 期
A phase III, partially blind, randomised, primary vaccination study to assess the immunogenicity and safety of three different lots of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine (MeMuRu-OKA), when given as a two-dose schedule to healthy children in their second year of life. - MeMuRu-OKA 043
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,442
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
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 subjects between 11 to 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 study end (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 present trial.
- •? 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).
- •? 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 <38.0°C.
- •? Rectal temperature ?38.0°C or axillary temperature ?37.5°C at the time of vaccination.
- •? Administration of immunoglobulins and/or any blood products within the six months before entering the study or planned administration during the study period.
研究者
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A phase III, partially blind, randomised, primary vaccination study to assess the immunogenicity and safety of three different lots of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine (MeMuRu-OKA), when given as a two-dose schedule to healthy children in their second year of life. - MeMuRu-OKA 043Active immunization of healthy children during their second year of life against measles, mumps, rubella and varicella diseases.EUCTR2004-005123-18-DEGlaxoSmithKline Biologicals1,442
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