EUCTR2007-004002-26-NL进行中（未招募）1 期
A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co-administration with Infanrix hexa™, when administered to infants as a three-dose primary vaccination course during the first six months of life and as a booster dose at 11-13 months of age. - 10PN-PD-DIT-027 PRI, 10PN-PD-DIT-027 BST
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 780
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 believes that their parents/guardian(s) 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, 6-12 weeks (42-90 days) of age at the time of the first vaccination.
- •Written informed consent obtained from both parents or from the guardian(s) of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of at least 36 weeks.
- •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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •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, >= 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 and up to one month (30 days) after each dose of study vaccine with the exception of pandemic influenza vaccine.
- •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
- •Children for whom hepatitis B vaccination is required according to the local recommendations or based on medical needs (for example if the mother is a hepatitis B virus carrier), should not be offered to participate in this randomised single blind study, in which two third of the subjects will not receive hepatitis B vaccination.
- •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease.
- •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 or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C for oral/axillary/tympanic measurements). Study entry should be delayed until the illness has improved.
- •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 and/or any blood products since birth or planned administration during the study period.
研究者
相似试验
进行中（未招募）
不适用
Primary vaccination course in healthy children receiving the pneu-mococcal vaccine GSK 1024850A co-administered with Tritanrix™-HepB/Hib at 6, 10 and 14 weeks of age.Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 10 weeks of age at the time of the first vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b 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: 100000004862EUCTR2011-004644-22-Outside-EU/EEAGlaxoSmithKline Biologicals360
进行中（未招募）
不适用
Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A or Prevenar™ co-administered with Hiberix™.Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae and Haemophilus influenzae type b 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: 100000004862EUCTR2015-001505-14-Outside-EU/EEAGlaxoSmithKline Biologicals503
进行中（未招募）
不适用
Safety and immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (GSK-580299) in healthy female children 4-6 years old.Healthy volunteersEUCTR2011-005604-15-Outside-EU/EEAGlaxoSmithKline Biologicals148
进行中（未招募）
不适用
Safety of Hib-MenCY-TT vaccine versus licensed Hib conjugate vaccine, given at 2, 4, 6 and 12 to 15 months of age.Haemophilus influenzae type b and Neisseria meningitidis serogroups C and YMedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 100000004862EUCTR2005-006066-34-Outside-EU/EEAGlaxoSmithKline Biologicals4,429
进行中（未招募）
不适用
A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cyclesEUCTR2013-003817-16-ESMerck KGaA946