EUCTR2014-004181-21-Outside-EU/EEA进行中（未招募）不适用
A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Given With DTaP Compared to Open-Label DTaP in Healthy Japanese Infants
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
- 551
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. Male or female subjects between 3 months and 6 months of age (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at the time of enrollment.
- •2. Available for the entire study period and whose parent/legal guardian can be reached by telephone.
- •3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- •4. Parent/legal guardian must be able to complete all relevant study procedures during subject participation. This includes the ability to understand and sign the ICF.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 551
- •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. Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
- •2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •3. Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, or pertussis vaccines.
- •4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
- •5. Known or suspected immune deficiency or suppression.
- •6. History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
- •7. Major known congenital malformation or serious chronic disorder (eg, Down syndrome, diabetes, sickle cell anemia).
- •8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb’s palsy.
- •9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis) within the past 3 months.
- •10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- •11. Infant who is a direct descendant (child, grandchild) of the study site personnel.
- •12. Infant who is judged by the investigator to be ineligible for study enrollment.
研究者
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