EUCTR2017-004069-29-FI进行中（未招募）1 期
Persistence of Anti-HBs Antibodies at 6 to 7 Years of Age in Subjects Having Received a DTaP-IPV-HB-PRP~T Hexavalent Vaccine at 3, 5, and 11 to 12 Months of Age, and Evaluation of Their Immune Memory Following a Challenge Vaccination with a Standalone Hepatitis B Vaccine
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 487
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
入选标准
- •Aged 6 to 7 years on the day of vaccination (6 to 7 years means from the day of the 6th birthday to the day before the 8th birthday).
- •-Informed Consent Form (ICF) has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed by the subject able to read.
- •-Receipt of 3 doses of either Hexyon or Infanrix hexa vaccine at the age of 3, 5, and 11 to 12 months in Study A3L38 with a post-dose 3 anti-hepatitis B (HB)s antibody titer available.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 487
- •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
- •-Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •-Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination except for influenza vaccination, which may be received less than 4 weeks before study vaccine.
- •-Subject known to have received HB containing vaccine after completion of Study A3L38 procedures.
- •-Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- •-Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- •-History or diagnosis of an of HB infection, confirmed either clinically, serologically, or microbiologically after completion of Study A3L38 procedures.
- •-Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
- •-Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
- •-Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •-Some criteria are temporarily exclusion criteria. In case a subject meets any of these criteria, a further appointment will be scheduled to reassess the subject’s eligibility.
研究者
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