EUCTR2015-001513-27-Outside-EU/EEA进行中（未招募）不适用
An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine administered as a three-dose primary vaccination course at 2-3-4 or 3-4-5 months of age in healthy infants in China. - DTPA-IPV (INFANRIX-IPV)-054
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
- 50
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 infant between, and including, 60 and 90 days of age at the time of the first study visit.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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
- •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) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B 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/or Hib disease.
- •Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
- •History of seizures or progressive neurological disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
研究者
相似试验
进行中（未招募）
不适用
An open label, Phase II study of vaccination with Survivin peptides emulsified in Montanide ISA 51VG after IMP 321 injection in prostate carcinoma patients with biochemical failure (PROVAX study) - NDProstate cancer, biochemical failure after all potentially curative standard local therapies (radiotherapy, brachytherapy and surgery) or biochemical progression while patients have castrated levels of testosterone or after first-line anti hormonal therapyMedDRA version: 12.1Level: LLTClassification code 10001200Term: Adenocarcinoma of the prostate stage IEUCTR2009-017798-39-ITISTITUTO NAZIONALE PER LA CURA TUMORI
已完成
不适用
A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Bedtime Dosing of JZP-324 (Extended Release Oxybate) for Oral Suspension in Healthy SubjectsNL-OMON50156Jazz Pharmaceuticals, Inc.16
进行中（未招募）
不适用
An open-label, non-controlled study to immunize healthy volunteers actively working with or in the vicinity of replicating Vaccinia virus with IMVAMUNE® (MVA-BN®)EUCTR2010-018334-51-DEBavarian Nordic A/S
进行中（未招募）
1 期
Treatment for Hospital-acquired pneumoniaSuspected Or Confirmed Nosocomial Pneumonia, Including Ventilator-Associated PneumoniaMedDRA version: 21.1Level: LLTClassification code 10052596Term: Nosocomial pneumoniaSystem Organ Class: 100000004862EUCTR2018-002841-12-SKPfizer Inc.32
进行中（未招募）
1 期
Treatment for Hospital-acquired pneumoniaEUCTR2018-002841-12-GBPfizer Inc.32