EUCTR2018-003787-31-BE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind, Active -comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,180
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. Is healthy (based on review of medical history and physical examination) based on the clinical judgement of the investigator.
- •2. Is male or female, approximately 2 months of age, from 42 days to 90 days inclusive, at the time of signing the informed consent.
- •3. Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1180
- •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. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- •2. Has a known hypersensitivity to any component of the PCV, any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
- •3. Has any contraindication to the concomitant study vaccines being administered in the study (concomitant vaccine contraindication details provided in the Investigator Trial File Binder).
- •4. Had a recent febrile illness (rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
- •5. Has a known or suspected impairment of immunological function.
- •6. Has a history of congenital or acquired immunodeficiency.
- •7. Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection.
- •8. Has, or his/her mother has, a documented hepatitis B surface antigen – positive test.
- •9. Has known or history of functional or anatomic asplenia.
- •10. Has failure to thrive based on the clinical judgement of the investigator.
- •11. Has a bleeding disorder contraindicating intramuscular vaccination.
- •12. Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet’s disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
- •13. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
- •14. Has received a dose of any pneumococcal vaccine prior to study entry.
- •15. Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry.
- •16. Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any other combination thereof, prior to study entry.
- •17. Meets one or more of the following systemic corticosteroid exclusion criteria:
- •a. Has received systemic corticosteroids (equivalent of =2 mg/kg total daily dose of prednisone or =20 mg/day for persons weighing >10 kg) for =14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization.
- •b. Has received or is expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
- •c. Is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study.
- •18. Has received other licensed non-live vaccines within 14 days before receipt of the first dose of study vaccines.
- •19. Has received a licensed live vaccine within 30 days before receipt of the first dose of study vaccines.
- •20. Has received a blood transfusion or blood products, including immunoglobulins.
- •21. Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor.
- •22. Has any other reason that, in the opinion of the investigator, may interfere with t
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