EUCTR2007-000261-38-BE进行中（未招募）1 期
A phase IV, open, multicentric study to evaluate the immune response to a hepatitis B challenge dose in healthy subjects, 72 to 78 months after they received a primary vaccination course of GSK Biologicals’ Engerix™-B (thiomersal-free 20 µg or preservative-free 10 µg) vaccine, in the primary study HBV-280. - HBV-314 BST: 280
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
- 250
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 they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit) should be enrolled in the study.
- •A male or female who received the complete primary vaccination course of hepatitis B vaccine (Engerix™-B), in the HBV-280 primary study.
- •Written informed consent obtained from the subject and/or parent/guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, and ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis B challenge dose.
- •Are the trial subjects under 18? yes
- •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
- •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) within 30 days preceding the hepatitis B vaccine challenge dose, 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 hepatitis B vaccine challenge 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 during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
- •Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <37.5°C (99.5°F) /axillary temperature <37.5°C (99.5°F).]
- •Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month).
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究者
相似试验
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
Study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin after birth.EUCTR2011-003731-63-Outside-EU/EEAGlaxoSmithKline Biologicals15
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 4-6 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, in clinical trials conducted by GSK Biologicals. - DTPa-HBV-IPV-111Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine, given as a three-dose primary vaccination series in the first year of life, followed by a booster in the second year of life: immune persistence and hepatitis B vaccine challenge at 4-6 years of age.EUCTR2006-000553-22-DEGlaxoSmithKline Biologicals300
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 (Engerix-B™ Kinder) vaccine challenge in children aged 7–8 years, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine - DTPA-HBV-IPV-113EUCTR2010-022538-10-DEGlaxoSmithKline Biologicals
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 7 to 9 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine or 4 doses of GSK Biologicals’ HBV vaccine, in clinical trials conducted by GSK Biologicals. - DTPa-HBV-IPV-110Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine or with GSK Biologicals’ HBV vaccine, given as a three dose primary vaccination series in the first year of life, followed by a booster in the second year of life: immune persistence and hepatitis B vaccine challenge at 7 to 9 years of age.EUCTR2006-000549-20-DEGlaxoSmithKline Biologicals150