EUCTR2012-004137-16-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomized, open-label, multicentre study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2-4-6 months of age in healthy infants in South Korea. - DTPA-IPV (INFANRIX-IPV)-059
适应症
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
- 454
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 between, and including, 42 and 69 days of age at the time of the first vaccination.
- •Born after a gestation period of 37 to 42 weeks inclusive.
- •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 visits).
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 454
- •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(s) within 30 days preceding the first dose, or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin (BCG) vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa 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).
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease.
- •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(s).
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Acute disease and/or fever at the time of enrolment.
- •-Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
- •-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
研究者
相似试验
进行中（未招募）
不适用
A phase III, randomized, open-label, multicenter study comparing GW572016 and Capecitabile (Xeloda) versus Capecitabile in women with refractory advanced or metastatic breast cancer.EUCTR2004-001456-36-ITGLAXO SMITHKLINE372
进行中（未招募）
不适用
Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Infanrix hexa™ vaccine in healthy infants in India.Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Hib diseases.EUCTR2013-003427-10-Outside-EU/EEAGlaxoSmithKline Biologicals214
招募中
3 期
A study to test the efficacy and safety in children of a vaccine developed by GlaxoSmithKline Biologicals for protection against multiple diseases, i.e. diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.CTRI/2012/02/002399GlaxoSmithKline Biologicals224
进行中（未招募）
不适用
Immunogenicity and safety study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with GSK Biologicals’ seasonal influenza vaccine GSK2321138A in adults aged 50 years and older.Healthy volunteers (Prevention of Herpes Zoster [HZ] and related complications in adults = 50 years of age [YOA ] and immunocompromised adults = 18 YOA.)MedDRA version: 17.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: HLTClassification code 10019972Term: Herpes viral infectionsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-000372-15-DEGlaxoSmithKline Biologicals828
进行中（未招募）
1 期
A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with rituximab (Mabthéra® ) after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy. - PRIMAMedDRA version: 8.1Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaFollicular lymphomaEUCTR2004-001756-36-CZGELA (Groupe d'Etude du Lymphome de l'Adulte)1,202