EUCTR2006-002898-47-GR进行中（未招募）1 期
A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine in preterm infants as a 3-dose primary immunisation course during the first 6 months of life - 10PN-PD-DIT-015
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
- 286
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
- •All subjects:
- •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.
- •A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Born after a gestation period of >27 weeks (at least 189 days).
- •Subjects of the Preterm I and Preterm II group:
- •Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks.
- •*Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery.
- •Subjects of the Full term group:
- •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:
- •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 vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up)
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine 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 one month (30 days) before the first dose of vaccines (Visit 1) and up to Visit 6.
- •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BGC vaccination)
- •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of any neurologic disorders or seizures.
- •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 temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°C )
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the active phase of the study.
研究者
相似试验
进行中（未招募）
不适用
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm InfantsEUCTR2006-002898-47-ESGlaxoSmithKline S.A.300
进行中（未招募）
不适用
Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine.Healthy volunteers (for three-dose primary vaccination against Streptococcus pneumoniae in healthy infants between 6 to 12 weeks of age at the time of the first vaccination)MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862EUCTR2012-000162-38-Outside-EU/EEAGlaxoSmithKline Biologicals300
招募中
1 期
CSL312_3003 Safety and Pharmacokinetic study in Subjects 2 to 11 Years of Age with Hereditary AngioedemaHereditary angioedema (HAE)MedDRA version: 20.0Level: PTClassification code: 10019860Term: Hereditary angioedema Class: 100000004850CTIS2022-502386-13-00CSL Behring LLC20
撤回
不适用
A 3-months open phase I study to assess the safety of the intrathecal application of Neuro-Cells in chronic traumatic spinal cord injury patientsNL-OMON46581europlast BV10
进行中（未招募）
不适用
A phase III open label study to evaluate safety and efficacy of Boceprevir-response guided therapy in controlled HIV patients with chronic hepatitis C genotype 1 infection who failed previously to Peginterferon /ribavirin.HCV and HIV seropositive coinfectionMedDRA version: 14.1Level: LLTClassification code 10065949Term: HCV coinfectionSystem Organ Class: 100000004862MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2012-003984-23-ESFundació Clínic per a la Recerca Biomèdica