EUCTR2011-005032-26-Outside-EU/EEA进行中（未招募）不适用
A phase III, open, randomized, controlled, multi-centre study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmithKline (GSK) Biologicals’ conjugate Hib-MenC vaccine co-administered with GSK Biologicals’ measles-mumps-rubella vaccine, Priorix™, versus MenC-CRM197 conjugate vaccine co-administered with GSK Biologicals’ Hib vaccine, Hiberix™, and Priorix™ in 12- to 18-month-old toddlers primed in infancy with a Hib vaccine but not with a meningococcal serogroup C vaccine; and to evaluate the long-term antibody persistence up to 5 years after the administration of the Hib-MenC vaccine. - HIB-MENC-TT-016, -017 EXT:016 Y1, -018 EXT:016 Y2, -019 EXT:016 Y3, -020 EXT:016 Y4, -021 EXT:016 Y5
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
- 433
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 whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 12 and 18 months of age at the time of 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 his/her parents’/guardians knowledge.
- •Having completed primary vaccination with two doses of Hib-OMP containing vaccine OR three doses of DTPa/Hib containing vaccine at least 6 months before the study start.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 433
- •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
- •Chronic or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination
- •Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before and ending 30 days after vaccination
- •Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose
- •Previous administration of a booster dose of Hib vaccine
- •Previous vaccination against measles, mumps, rubella
- •History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases
- •Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including 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
- •Major congenital defects or serious chronic illness
- •History of neurological disorders or more than one episode of febrile convulsion
- •Acute disease at the time of enrolment
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- •For the long-term persistence phase:
- •Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines
- •History of H. influenzae type b, meningococcal serogroup C diseases
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