EUCTR2011-004905-26-CZ进行中（未招募）1 期
Immunogenicity and safety study of GSK Biologicals’ Priorix® vaccine (209762) at an end of shelf-life potency compared to Merck & Co., Inc.’s MMR vaccine when both are given on a 2-dose schedule to healthy children in their 2nd year of life. - MMR-161
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
- 4,500
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
- •Male or female child between 12 and 15 months of age at the time of vaccination.
- •The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s)/LAR(s) of the child.
- •Child is in stable health as determined by investigator’s clinical examination and assessment of child’s medical history.
- •For US children only:
- •Child that previously received a 3-dose series of Prevnar 13 at least 60 days prior to study entry.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4500
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination or planned use during the entire study period.
- •Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
- •Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
- •-Inhaled and topical steroids are allowed.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:
- •-Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
- •-Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.
- •Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the US post-dose 2 sub-cohort.
- •History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
- •Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the first study vaccination.
- •Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin.
- •Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- •Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature =38°C/100.4°F by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
- •Active untreated tuberculosis based on medical history.
- •Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
- •For US children only:
- •A child that previously received a fourth dose of any pneumococcal conjugate vaccine.
研究者
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