EUCTR2011-001608-37-IT进行中（未招募）1 期
Open, randomised, controlled, multicenter Phase IIIb study to evaluate the immune response and safety, after the administration of GlaxoSmithKline Biologicals live attenuated measles mumps rubella varicella (MMRV) combination vaccine (Priorix tetra) or MMRV + conjugated meningococcal C vaccine (MenC) (Meningitec, Wyeth Vaccines) given to healthy children - MMRV-063
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
- 716
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 parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). • A male or female between, and including, 13 and 15 months of age at the time of the first vaccination. • Written informed consent obtained from the parent(s)/LAR(s) of the subject. • Healthy subjects 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: 808
- •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
- •Child in care • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ( 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). • Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C. • History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases. • Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness. • Acute disease and/or fever at the time of enrolment. ? Fever is defined as temperature = 37.5°C /99.5°F on oral, axillary or tympanic setting, or = 38.0°C /100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary. ? Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • Documented human immunodeficiency virus (HIV)-positive subject. • Any contraindications as stated in the Summary of Product Characteristics. • Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
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