EUCTR2004-001249-14-ES进行中（未招募）1 期
A Phase III open, multicentre, booster vaccination study to assess the immunogenicity, safety and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine (Hib-MenC) compared to a booster dose of INFANRIX HEXA (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Hib vaccine) when given to 14-month-old subjects who were primed in study 217744/097 (DTPa-HBV-IPV-097). - Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097
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
- 468
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, 13 and 14 months of age at the time of booster 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.
- •? Having participated in the primary vaccination study 217744/097
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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 booster 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.)
- •? Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster vaccine.
- •? Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097.
- •? History of diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C disease.
- •? Known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C disease within the last 3 months.
- •? 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.
- •? Major congenital defects or serious chronic illness.
- •? History of any neurologic disorders or seizures including febrile seizures (at least 2 events) in infancy.
- •? 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., Oral temperature <37.5°C / Axillary temperature <37.5°C / Rectal temperature <38°C.
- •? Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
研究者
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