EUCTR2006-006580-23-FI进行中（未招募）不适用
Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ MMRV vaccine (Priorix-Tetra™) in healthy 12 to 23-month-old children. - MenACWY-TT-039
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.
- •A male or female between, and including, 12 and 23 months of age at the time of the 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.
- •Previously completed routine childhood vaccinations to the best of parents’ or legal guardians’ knowledge.
- •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 vaccine dose. (For corticosteroids, this will mean >= 0.5 mg/kg/day prednisone or equivalent. Inhaled and topical steroids are allowed.)
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the dose of vaccine(s).
- •Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- •History of meningococcal disease
- •Previous vaccination against measles, mumps, rubella, and/or varicella.
- •History of measles, mumps, rubella or varicella.
- •Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
- •Major congenital defects or serious chronic illness.
- •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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F) / Tympanic temperature on oral setting <37.5°C (99.5°F)
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
研究者
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