EUCTR2012-002401-22-Outside-EU/EEA进行中（未招募）不适用
A Phase III, open, randomized, controlled, multicenter study to assess the safety and immunogenicity of GlaxoSmithKline’s Biologicals’ (GSK Biologicals) Neisseria meningitidis serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as compared to GSK Biologicals’ Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (Hib-MenCY-TT) in healthy toddlers 12-15 months of age who were primed at 2, 4 and 6 months of age with Hib-MenCY-TT and Pediarix®, and to assess the safety and immunogenicity of MenACWY-TT co-administered with Infanrix® in healthy toddlers 15-18 months of age who were primed with HibMenCY-TT and Pediarix® at 2, 4, and 6 months of age as compared to the administration of Infanrix® alone in healthy toddlers 15-18 months of age who were primed with ActHIB® and Pediarix® at 2, 4 and 6 months of age - MENACWY-TT-057 PRI; -057 BST
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
- 1,558
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 the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after 36 weeks gestation.
- •For inclusion in the booster phase, subjects must have received all three doses in the primary phase
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1558
- •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
- •Exclusion criteria for enrolment (primary phase)
- •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) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, per-tussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition based on medical history and physical examination
- •History of allergic disease or reactions likely to be exac-erbated by any component of the vaccines, or by dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrent participation 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).
- •Exclusion criteria for enrolment (booster phase)
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
- •Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
- •Previous administration of a booster dose of Hib prior to entry to the booster phase.
- •Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
- •Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
- •Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
- •History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exac-erbated by any component of the vaccines, or by dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products within the past 3 months or planned administra-tion during the study period.
- •Concurrent participation in another clinical st
研究者
相似试验
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
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: 014EUCTR2005-005421-59-FIGlaxoSmithKline Biologicals709
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