EUCTR2011-004456-19-Outside-EU/EEA进行中（未招募）不适用
Phase III, open-label, multi-center booster vaccination study in toddlers who completed a three-dose primary series of the DTaP-IPV-Hep B-PRP-T combined vaccine or Infanrix hexa™ in Study A3L11.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,190
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) Toddlers previously included in Study A3L11 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
- •2) Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
- •3) Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
- •4) Able to attend all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1190
- •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 in the 4 weeks preceding the booster vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
- •4) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
- •5) Chronic illness at a stage that could interfere with trial conduct or completion 6) Blood or blood-derived products received in the last 3 months
- •7) Any vaccination in the 4 weeks preceding the booster vaccination
- •8) Any vaccination planned until the next visit
- •9) History of documented pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- •10) Administration of a vaccine against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, and/or hepatitis B infection(s) since the end of participation in Study A3L11
- •11) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •12) Known maternal history of HIV, hepatitis B (HBsAg) or hepatitis C seropositivity.
- •13) Subjects with any related SAE that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11
- •14) History of seizures
- •15) Febrile (temperature =38.0°C) or acute illness on the day of inclusion
- •16) Known contraindication to further vaccination with a pertussis vaccine, i.e.:
- •- Encephalopathy
- •- Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series
- •- Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series
- •- Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series
- •- Seizures with or without fever within 3 days following vaccine injection
研究者
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