EUCTR2013-001918-15-BE进行中（未招募）不适用
A phase IV, open-label, single-centre study to assess the long-term persistence of hepatitis A antibodies in healthy adults, primed 21 to 25 years earlier with GSK Biologicals’ hepatitis A vaccine Havrix® (SB208109) in studies HAV-112 (208109/108) or HAV-123 (208109/114). - HAV-248
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •A male or female who received two doses of Havrix in study HAV-112 (208109/108) or HAV-123 (208109/114), and received no further booster dose since then.
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
- •Written informed consent obtained from the subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •History of hepatitis A disease since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114).
- •Administration of a hepatitis A vaccine at any time since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- •Administration of hepatitis A immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
- •Concurrently participating in another clinical study, during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
研究者
相似试验
进行中（未招募）
1 期
ong term immunogenicity up to 15 years after the first booster immunization with GSK Biologicals’Encepur Adults in adults who received 1 of 3 different primary vaccination schedules.EUCTR2017-001356-59-CZGlaxoSmithKline Biologicals200
进行中（未招募）
1 期
A phase IV clincal study to evaluate antibody responses through 6 to 10 yearsafter after first booster with TBE vaccine.EUCTR2011-003255-19-CZGlaxoSmithKline Biologicals SA
进行中（未招募）
1 期
ong-term hepatitis A and B antibody persistence in healthy adult subjects, primed 16 to 20 years earlier with GSK Biologicals’ combined hepatitis A and B vaccine, Twinrix® (SB208127) in study HAB-084 (208127/084).Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults)MedDRA version: 16.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-004586-13-CZGlaxoSmithKline Biologicals s.a.180
已完成
不适用
Persistence of antibodies six years after priming immunisation with Meningococcal C conjugate vaccine and response to the Hib-MenC (Menitorix®) vaccine in healthy childreMeningococcal C and Haemophilus influenzae type B diseasesInfections and InfestationsISRCTN72858898niversity of Oxford (UK)250
进行中（未招募）
1 期
A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).EUCTR2014-004904-31-NLMundipharma Pharmaceuticals B.V.