EUCTR2011-003710-16-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomized, open, controlled study in healthy Japanese children to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa vaccine as a 3-dose pri-mary immunization course at 3, 4 and 5 months of age and followed by a booster vaccination at 17-19 months of age. - 10PN-PD-DIT-058
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
- 360
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/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
- •Written informed consent obtained from the par-ent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 360
- •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 vaccine(s), or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
- •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).
- •Administration of any pneumococcal vaccine since birth except for subjects receiving the DTPa vaccine only (DTPa Group) for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of, or intercurrent diphtheria, tetanus, pertussis disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any seizures or progressive neurological disease.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Child in care.
- •Acute disease and/or fever at the time of enrolment.
研究者
相似试验
进行中（未招募）
不适用
Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A co-administered with Zilbrix™ Hib and Polio Sabin™Healthy volunteers (Three dose primary vaccination of healthy infants against Streptococcus pneumonia, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and polio diseases)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: 100000004862EUCTR2011-004650-25-Outside-EU/EEAGlaxoSmithKline Biologicals365
进行中（未招募）
不适用
A phase III, open, randomized, controlled study to demonstrate the immunogenicity, reactogenicity and safety of GSK Biologicals meningococcal serogroup ACWY conjugate vaccine (GSK134612, MenACWY-TT) co-administered with Infanrix hexacompared to individual administration of each vaccine, in healthy 12- through 23-month-old children - MenACWY-TT-040One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 monthsEUCTR2006-006680-23-ATGlaxoSmithKline Biologicals
进行中（未招募）
不适用
A phase III, open, randomized, controlled study to demonstrate the immunogenicity, reactogenicity and safety of GSK Biologicals meningococcal serogroup ACWY conjugate vaccine (GSK134612, MenACWY-TT) co-administered with Infanrix hexacompared to individual administration of each vaccine, in healthy 12- through 23-month-old children - MenACWY-TT-040One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 monthsEUCTR2006-006680-23-DEGlaxoSmithKline Biologicals
进行中（未招募）
1 期
A phase III, open, randomized, controlled study to demonstrate the immunogenicity, reactogenicity and safety of GSK Biologicals meningococcal serogroup ACWY conjugate vaccine (GSK134612, MenACWY-TT) co-administered with Infanrix hexacompared to individual administration of each vaccine, in healthy 12- through 23-month-old children - MenACWY-TT-040One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 monthsEUCTR2006-006680-23-GRGlaxoSmithKline Biologicals793
已完成
不适用
A phase III open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to comparator vaccine in healthy children and adolescents (12 months to 16 years of age inclusive), using a 0/6 month scheduleHepatitis A VirusInfections and InfestationsHepatitisISRCTN91009479Berna Biotech AG (Switzerland)360