EUCTR2019-004503-12-Outside-EU/EEA进行中（未招募）1 期
A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulation (e.g., Health Insurance Portability and Accountability Act authorization) must be obtained from the subject’s parent/legal guardian.
- •2. Subject is a healthy toddler, approximately 12 to 15 months of age who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
- •3. Subject is afebrile within the last 48 hours (temperature measured orally is < 100 F [37.8°C]; measured rectally or tympanic is < 101 F [38.3°C]; measured in an axillary position or temporal is < 98.4 F [36.9°C]).
- •4. Subject’s parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
- •5. Subject’s parent/legal guardian along with the subject is able and is willing to attend all scheduled visits and to comply with the study procedures.
- •6. Subject’s parent/legal guardian has access to a telephone.
- •7. Subject’s parent/legal guardian agrees not to enroll subject in another interventional study while participating in the present study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •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. Subject has a known hypersensitivity to any vaccine.
- •2. Subject has an immune disorder(s) (including autoimmune disease) and/or clinical
- •conditions requiring immunosuppressive drugs, known or suspected impairment of
- •immunological function or a history of congenital or acquired immunodeficiency.
- •3. Subject has or his/her mother has known human immunodeficiency virus infection or
- •known to be hepatitis B surface antigen-positive.
- •4. Subject has functional or anatomic asplenia.
- •5. Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
- •6. Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, as judged by the investigator.
- •7. Subject has any active malignancy or history of malignancy.
- •8. Subject has been in receipt of intramuscular, oral, intravenous, inhaled or intranasal corticosteroid treatment within 2 weeks prior to study vaccination or is planned to receive these medications within 4 weeks after study vaccination. Note: Use of topical corticosteroids is permitted.
- •9. Subject has received any live-attenuated vaccines within 4 weeks prior to receipt of the study vaccine or inactivated vaccines within 2 weeks prior to receipt of study vaccine.
- •10. Subject has previously received an approved (other than PCV13) or investigational pneumococcal vaccine.
- •11. Subject has had any prior receipt of a blood transfusion or blood products, including immunoglobulins.
- •12. Subject has received investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
- •13. Subject has received a systemically absorbed antibacterial agent within 7 days prior to study vaccination.
- •14. Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
- •15. Subject has received acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) within 24 hours prior to receipt of study vaccine.
- •16. Subject has a coagulation disorder.
- •17. Subject’s parent/legal guardian is (in the opinion of the investigator) unlikely to adhere to study procedures, keep appointments or is planning to relocate during the study and the subject cannot be adequately followed for safety according to the protocol.
- •18. Subject who has a condition, which, in the opinion of the investigator, makes the subject unsuitable for study participation.
- •19. Subject’s parent(s)/legal guardian is an employee of APGD, the study-related contract research organizations (CROs) or the study site.
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