EUCTR2011-004450-26-Outside-EU/EEA进行中（未招募）不适用
Phase III, multi-center study in children fully vaccinated with a three-dose primary and the booster dose of the DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B in Study A3L15.
Sanofi Pasteur SA0 个研究点目标入组 567 人开始时间: 2012年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 567
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
- •1) Aged 3 years and a half on the day of inclusion (42 months ± 60 days)
- •2) Informed consent form signed by a parent or other legally acceptable
- •representative and by an independent witness if the parent or other legal guardian is illiterate.
- •3) Subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures.
- •4) Receipt of primary vaccination with 3 doses of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV + Engerix™ B and a booster dose of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™+ OPV.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 567
- •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
- •1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial.
- •2) Incomplete primary and booster immunization at trial A3L15.
- •3) Previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza b or hepatitis B after completion of A3L15 Study.
- •4) Subjects known to have received diphtheria, tetanus, pertussis, Haemophilus influenza b and hepatitis B vaccination after completion of A3L15 Study.
- •5) Any vaccination within 30 days preceding inclusion, except for measles or poliovirus (monovalent) containing vaccines and pandemic influenza vaccines including pandemic H1N1-2009 strain, which may be received at least two weeks before the subject's blood sample collection
- •6) Blood or blood-derived products received at the latest 3 months before inclusion, receipts of immunosuppressant drugs within the previous 3 months.
- •7) Known or suspected congenital or acquired immunodeficiency since completion of A3L15 Study.
- •8) Serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma [Tor B cells], Crohn's disease).
- •9) Known or suspected subject seroconversion for HIV or hepatitis C seropositivity since completion of A3L15 Study.
- •10) Febrile (temperature =38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
- •Criteria 1, 5, 6 and 10 are temporary exclusion criteria. A further appointment can be scheduled.
研究者
相似试验
进行中（未招募）
不适用
Booster and Catch-up Vaccination With Vaccine GSK1024850AHealthy volunteers (Vaccination against Streptococcus pneumoniae in healthy children previously enrolled in study 10PN-PD-DIT-037 (111188).)MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002140-27-Outside-EU/EEAGlaxoSmithKline Biologicals360
进行中（未招募）
不适用
Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-HB-Hib Combined Vaccine in a 3-dose Primary Series in Healthy Infants in EuropePrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virusMedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2012-001055-39-ESSanofi Pasteur SA795
进行中（未招募）
不适用
Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-HB-Hib Combined Vaccine in a 3-dose Primary Series in Healthy Infants in EuropePrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virusMedDRA version: 17.0Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2012-001055-39-CZSanofi Pasteur SA795
进行中（未招募）
不适用
Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-HB-Hib Combined Vaccine in a 3-dose Primary Series in Healthy Infants in EuropePrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virusMedDRA version: 17.0Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2012-001055-39-DESanofi Pasteur SA795
进行中（未招募）
1 期
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Boostrix™ vaccine and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years.Healthy volunteers (Immunisation against diphtheria, tetanus and pertussis)MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-000644-34-Outside-EU/EEAGlaxoSmithKline Biologicals660