EUCTR2020-003329-49-Outside-EU/EEA进行中（未招募）1 期
A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants
适应症
相关药物
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. Is healthy Chinese infant.
- •2. Is male or female from48 days to 63 days of age (inclusive) at Visit 1. (Date of birth is 1 day of age).
- •3. The participant’s legally acceptable representative provides written informed consent for the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •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 history of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea, failure to thrive, or abdominal surgery.
- •2. Has history of intussusception.
- •3. Has history of poliomyelitis.
- •4. Has clinical evidence of active gastrointestinal illness.
- •5. Has known or suspected impairment of immunological function, including severe combined immunodeficiency disease (SCID).
- •6. Has a fever, with an axillary temperature =37.5°C (or equivalent) at the time of vaccination or within 24 hours prior to vaccination.
- •7. Participant who clearly has acute disease.
- •8. Participant who has underlying diseases such as cardiovascular, renal, liver, or blood disease.
- •9. Has history of known hypersensitivity to any components of rotavirus vaccine and/or IPV.
- •10. Participant with uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological diseases.
- •11. Participant with known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •12. Is residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV) infection, leukemia, lymphoma, multiple myeloma, generalized malignance, chronic renal failure, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
- •13. Has prior administration of any rotavirus vaccines or poliovirus vaccines.
- •14. Received inactivated or recombinant vaccines within 14 days prior to Visit 1 or live vaccines within 28 days prior to Visit 1.
- •15. Has prior receipt of investigational or non-registered product other than study vaccines or is planning to use such product during the study.
- •16. Has prior receipt of immunosuppressive therapies including systemic (intramuscular, oral, or intravenous) corticosteroids.
- •17. Has prior receipt of a blood transfusion or blood products, including immunoglobulins or is planning to receive such product during the study.
- •18. Participated in another interventional study prior to Visit 1 or expected anytime during the study.
研究者
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