EUCTR2017-000454-18-Outside-EU/EEA进行中（未招募）1 期
A Phase II randomized, observer blind, multicenter study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella-varicella vaccine (MMRV) versus ProQuad, according to a one dose schedule, both administered subcutaneously at 12-14 months of age, concomitantly with hepatitis A vaccine (HAV) and pneumococcal conjugate vaccine (PCV) but at separate sites. - MMRV-054 PRI
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
- 1,851
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 for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •Male or female between 12 and 14 months of age at the time of first vaccination.
- •Written informed consent obtained from the parent/guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1851
- •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 other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •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.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
- •Previous vaccination against measles, mumps, rubella and/or varicella.
- •Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
- •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 study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, 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 vaccines.
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •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.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
- •Previous vaccination against measles, mumps, rubella and/or varicella.
- •Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
- •History of measles, mumps, rubella and/or varicel-la/zoster diseases.
- •Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be ex-acerbated by any component of the vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures. Un-complicated febrile convulsions are not an exclusion criterion.
- •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.
- •?- Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
- •?- Persons with known immunodeficiency.
- •Acute disease at the time of enrolment. All vaccines can be administered
研究者
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