EUCTR2011-004451-39-Outside-EU/EEA进行中（未招募）不适用
Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination with Investigational (DTaP-IPV-HB-Hib) or Infanrix™ hexa vaccines in Latin America
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
- 699
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
- •A potential subject had to meet all of the following criteria to be considered for trial
- •enrollment:
- •1) Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
- •2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
- •3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •4) Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-HB-Hib or Infanrix™ hexa, concomitantly administered with Prevenar™ [PCV7] and Rotarix™) and a booster dose during the trial A3L27 (either DTaP-IPV-HB-Hib
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 558
- •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
- •A potential subject meeting any of the following criteria was ineligible for trial enrollment:
- •1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •2) Incomplete primary and booster immunization at trial A3L24 and A3L27
- •3) Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
- •4) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study
研究者
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