EUCTR2011-003731-63-Outside-EU/EEA进行中（未招募）不适用
A phase IV, open, multi-centre study to assess the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin at birth. - Rota-077 PMS
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
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 parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Infants who have received a previous dose of hepatitis B immunoglobulin after birth.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •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
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs with the exception of HBIG since birth. For corticosteroids, prednisone >20 mg/day, or equivalent, inhaled and topical steroids are allowed.
- •Child is unlikely to remain in the study area for the duration of the study.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
- •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).
- •Previous vaccination against RV.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •Acute disease and/or fever at the time of enrolment.
- •-Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting, or = 38.0°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be tympanic on rectal setting.
- •-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
- •GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- •Previous confirmed occurrence of RV GE.
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 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
进行中（未招募）
不适用
Open, multicenter, phase IV study to evaluate the safety and effectiveness of peginterferon alfa-2a (40 KD) associated with ribavirin for the treatment chronic hepatitis C with persistent normal ALT in HIV coinfected patientsComparate the safety and effectivenes of the treatment with peginterferon alfa-2a in combination with ribavirin between HIV/HCV coinfected patients with persistent normal ALT levels versus HIV/HCV coinfected patients with high ALT levelsEUCTR2006-001243-55-ESMiguel Santin Cerezales230
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