EUCTR2014-000750-11-Outside-EU/EEA进行中（未招募）不适用
Study to compare immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose presentation to the licensed Synflorix™ (10Pn-PD-DiT) vaccine when co-administered with DTPw-combination vaccine in healthy infants. - 10PN-PD-DIT-086
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
- 320
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 for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits).
- •A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
- •Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born full-term (i.e., after a gestation period from 37 to 42 weeks).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 320
- •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 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 since birth. Inhaled and topical steroids are allowed.
- •Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
- •Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions:
- •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 vaccine/product
- •Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b and/or S. pneumoniae.
- •History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H. influenzae type b disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •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.
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature = 37.5°C for oral, axillary or tympanic route, or = 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
- •Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- •Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
研究者
相似试验
尚未招募
不适用
Immunogenicity & safety of GSK Biologicals malaria vaccine given at 6,7.5 &9 months of age coadministered with measles,rubella & yellow fever vaccinesPaediatricsMalariaPACTR201602001483150GlaxoSmithKline Biologicals700
进行中（未招募）
不适用
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella (MMR) vaccine in children in their second year of life.EUCTR2011-004905-26-FIGlaxoSmithKline Biologicals4,500
进行中（未招募）
1 期
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella (MMR) vaccine in children in their second year of life.Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life).MedDRA version: 14.1Level: PTClassification code 10028257Term: MumpsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10039252Term: RubellaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10027011Term: MeaslesSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004905-26-CZGlaxoSmithKline Biologicals4,500
进行中（未招募）
不适用
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? combined measles-mumps-rubella (MMR) vaccine in children in their second year of life.Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life).MedDRA version: 14.1Level: PTClassification code 10028257Term: MumpsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10039252Term: RubellaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10027011Term: MeaslesSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004905-26-ESGlaxoSmithKline4,500
进行中（未招募）
不适用
Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ MMRV vaccine (Priorix-Tetra™) in healthy 12 to 23-month-old children. - MenACWY-TT-039One dose primary immunization against Neisseria meningitidis serogroups A, C, W-135, and Y when given alone or when co-administered with a first dose of Priorix-Tetra in healthy children aged 12 to 23 months.EUCTR2006-006580-23-FIGlaxoSmithKline Biologicals