EUCTR2006-006460-32-GB进行中（未招募）1 期
A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine given at 12-15 months of age to subjects who were primed in primary study 103974 (HIB-MENC-TT-012) and boosted in study 104056 (HIB-MENC-TT-013 BST:012). - Hib-MenC-TT-027, 028, 029
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 478
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
- •All subjects must satisfy the following criteria at study entry:
- •Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- •A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Having completed the booster vaccination study HIB-MENC-TT-013 BST:012.
- •Subjects of group NoBoost at Visit 2 (UK only):
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between and including 40 and 43 months of age at Visit 2.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.
- •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
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
- •Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study HIB-MENC-TT-013 BST:012.
- •History of H. influenzae type b or meningococcal diseases.
- •UK subjects only: previous administration of a booster dose of a pertussis-containing vaccine, except booster study vaccines during the study HIB-MENC-TT-013 BST:012 (104056)
- •Subjects of group NoBoost at Visit 2 (UK only):
- •Previous administration of a booster dose of Hib or meningococcal serogroup C vaccine
- •History of H. influenzae type b or meningococcal diseases
- •The following criteria should be checked at each visit subsequent to the first visit for subjects in groups HibMenC and LicMenC:
- •History of H. influenzae type b, meningococcal or pertussis diseases* since the previous long-term persistence visit [for the Visit1 - since the last visit of the booster vaccination study 104056 (HIB-MENC-TT-013 BST:012)].
- •* Subjects with a history of pertussis disease will be eliminated from the pertussis analyses only. See Section 9.3.
- •Previous administration of a booster dose of Hib or meningococcal serogroup C vaccines since the previous long-term persistence visit.
- •UK subjects only: Prior to Visit 2: previous administration of pertussis containing vaccine as booster vaccination.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since the last visit. (For corticosteroids, this will mean prednisone, or equivalent, ?0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
- •Administration of immunoglobulins and/or any blood products since the last visit.
研究者
相似试验
进行中（未招募）
1 期
A phase IV, open, multicentre, multicountry study to evaluate the immune response to a challenge dose of GSK Biologicals’ Twinrix™ vaccine versus monovalent hepatitis A and B vaccines from different manufacturers in healthy and non-healthy adults aged > 41 years, approximately 48 months after primary vaccination in study 100382 (HAB-160). - HAB-168 BST:160EUCTR2008-000526-39-CZGlaxoSmithKline Biologicals333
进行中（未招募）
不适用
A phase IV, open, multicentre, multicountry study to evaluate the immune response to a challenge dose of GSK Biologicals’ Twinrix™ vaccine versus monovalent hepatitis A and B vaccines from different manufacturers in healthy and non-healthy adults aged > 41 years, approximately 48 months after primary vaccination in study 100382 (HAB-160). - HAB-168 BST 160Healthy and non-healthy (including those taking medications) adults older than 41 years who participated in the primary vaccination study HAB-160 approximately 48 months ago.EUCTR2008-000526-39-BEGlaxoSmithKline Biologicals333
进行中（未招募）
1 期
A study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in HIV+ patients.EUCTR2019-000199-41-ESFundación SEIMC-GESIDA234
进行中（未招募）
不适用
An open, phase IV, multicentre, study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children aged 11-12 years, previously vaccinated with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) or GSK Biologicals’ DTPa-IPV/Hib and HBV (Engerix™- B) vaccines at the ages of 3, 5 and 11 months in clinical trial DTPa-HBV-IPV-031 (217744/031). - DTPa-HBV-IPV-126 BST:031Antibody persistence and hepatitis B vaccine challenge at 11-12 years of age (excluding 13th birthday), after primary vaccination with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or GSK Biologicals’ HBV vaccine (Engerix-B) given at the ages of 3, 5 and 11 months.EUCTR2009-016911-39-SKGlaxoSmithKline Biologicals
进行中（未招募）
不适用
An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in adolescents 12-13 years of age who were vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B). - HBV-318Antibody persistence and hepatitis B vaccine challenge in adolescents aged 12-13 years, vaccinated in infancy with three doses of GSK Biologicals’ HBV vaccine in routine practice.EUCTR2009-012117-21-DEGlaxoSmithKline Biologicals