EUCTR2011-005881-38-Outside-EU/EEA进行中（未招募）不适用
A phase II, randomized, double-blind study of Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine), one lot using new measles and rubella working seeds and one lot using old working seeds, in healthy subjects aged 11 to 21 months - MEMURU-OKA-049
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 498
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, 11 and 21 months of age (e.g. from age 11 months 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 501
- •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.)
- •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.
- •† Inactivated H1N1 influenza vaccine can be given at ANY time to subjects in Taiwan only.
- •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. (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. Axillary temperature < 37.5°C (99.5°F) / Rectal temperature < 38°C (100.4°F).
- •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
- •Hypersensitivity to latex.
研究者
相似试验
进行中（未招募）
不适用
A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small Cell Lung CancerEUCTR2006-005122-23-SEMerck Sharp & Dohme (Sweden) AB1,000
进行中（未招募）
1 期
A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat (MK-0683) or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)MedDRA version: 8.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIBEUCTR2006-005122-23-LVMerck & Co., Inc.1,000
进行中（未招募）
不适用
A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat (MK-0683) or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC) - NDPatients with Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC).MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancerEUCTR2006-005122-23-ITMERCK SHARP DOHME1,000
进行中（未招募）
1 期
A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat (MK-0683) or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)MedDRA version: 8.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIBEUCTR2006-005122-23-CZMerck & Co., Inc.1,000
进行中（未招募）
1 期
A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small Cell Lung CancerStage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)MedDRA version: 8.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIBEUCTR2006-005122-23-DKMerck & Co., Inc.1,000