EUCTR2005-005421-59-FI进行中（未招募）1 期
A phase III, open, randomized, controlled, multicentre, primary & booster study to demonstrate the non-inferiority of the MenC & Hib immune responses of GSK Biologicals’ Hib-MenC vaccine co-administered with Infanrix™ penta versus NeisVac-C™ co-administered with Infanrix™ hexa when given as 2 primary doses at 3, 5 m of age & prior to a booster dose at 11 m, as well as the immunogenicity of the Hib-MenC vaccine given as a booster at 11 m & the persistence of antibodies prior to the booster dose. - Hib-MenC-TT-014; Hib-MenC-TT-015 BST: 014
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 709
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
入选标准
- •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 healthy male or female subject, between and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period between and including 36 and 42 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) since birth or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressant 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 since birth, with exception of BCG.
- •Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease
- •History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •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 low-grade febrile illness, i.e. Rectal temperature <38°C.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Additional specific criteria for the booster phase of the study (to be checked at Visit 4)
- •Previous booster vaccination with a Hib vaccine.
- •Previous booster vaccination with a serogroup C meningococcal vaccine.
- •Previous booster vaccination with a DTP containing vaccine.
- •Previous booster vaccination with a IPV containing vaccine.
- •Previous booster vaccination with a Hep B containing vaccine.
研究者
相似试验
进行中（未招募）
不适用
on-inferiority of meningococcal vaccine GSK134612 versus Mencevax™ in 11-17 year-old subjectsMeningococcal diseaseMedDRA version: 14.1Level: LLTClassification code 10027275Term: Meningococcal infection, unspecifiedSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-000282-20-Outside-EU/EEAGlaxoSmithKline Biologicals1,025
进行中（未招募）
不适用
A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine when given as one dose with Twinrix™ versus GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine alone and versus Twinrix™ alone in healthy subjects aged 11 through 17 years - MenACWY-TT-037Primary immunization of healthy subjects aged 11 through 17 years against meningococcal serogroups A, C, W 135 and Y and/or hepatitis A and hepatitis B diseasesEUCTR2006-005999-41-SEGlaxoSmithKline Biologicals600
进行中（未招募）
不适用
A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine when given as one dose with Twinrix™ versus GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine alone and versus Twinrix™ alone in healthy subjects aged 11 through 17 years - MenACWY-TT-037Primary immunization of healthy subjects aged 11 through 17 years against meningococcal serogroups A, C, W 135 and Y and/or hepatitis A and hepatitis B diseasesEUCTR2006-005999-41-DKGlaxoSmithKline Biologicals600
进行中（未招募）
不适用
Immunogenicity & safety study of a booster dose of GSK Biologicals’ meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in primed healthy toddlersHealthy volunteers (for active immunization against N. meningitidis serogroups A, C, W-135 and Y when given as a booster dose for the MenC and MenY antigens and as a priming dose for the MenA and MenW-135 antigens in toddlers 12 to 18 months of age who were primed in infancy with Hib-MenCY-TT and Pediarix® at 2, 4, and 6 months of age)MedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848EUCTR2012-002401-22-Outside-EU/EEAGlaxoSmithKline Biologicals1,558
进行中（未招募）
不适用
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ meningococcal vaccine with or without co-administration of a licensed viral vaccine and Boostrix in female adolescents and young adults.Meningococcal diseaseMedDRA version: 16.1Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862MedDRA version: 16.1Level: LLTClassification code 10032810Term: Other specified meningococcal infectionsSystem Organ Class: 100000004862MedDRA version: 16.1Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848EUCTR2012-001876-13-EEGlaxoSmithKline Biologicals1,300