EUCTR2017-000277-37-Outside-EU/EEA进行中（未招募）1 期
Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants - Immunogenicity and safety assessment of V260 and DTP-IPV in Japanese 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）
- 入组人数
- 192
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. Healthy Japanese infants.
- •2. Age 6 weeks through less than 11 weeks (=42 days to =76 days from Date of Birth) at Visit 1.
- •3. Parent/legal guardian understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. The parent/guardian may also provide consent for Future Biomedical Research. However, the patient may participate in the main trial without participating in the Future Biomedical Research.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 192
- •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
- •At Visit 1, subjects should not have any exclusion criteria. As for exclusion criteria with an asterisk [*], if the subject meets this criterion at any visit, the visit may be resche duled when the criterion no longer applies.
- •1. * Subjects who are clearly feverish, axillary temperature =37.5ºC at the time of vaccination.
- •2. * Subjects who clearly have acute active disease.
- •3. Subjects with a history or a risk of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 and/or DTP-IPV.
- •4. Subjects with gastrointestinal disorder (active gastrointestinal disease, chronic diarrhea, prior rotavirus gastroenteritis, abdominal surgery), growth retardation, or failure to thrive.
- •5. Subject with history of intussusception.
- •6. Subject with untreated congenital gastrointestinal disorder (such as Meckel diverticulum) that may increase the onset of intussusceptions.
- •7. Known or suspected impairment of immunological function, including severe combined immunodeficiency (SCID).
- •8. Subjects who have underlying diseases such as cardiovascular, renal, liver, or blood diseases.
- •9. Subjects with a history of convulsion.
- •10. Subjects undergoing immunosuppressive therapy (including high -dose systemic corticosteroids [?2mg/kg/day of prednisolone or equivalent] ) or subjects living with a close relative with congenital immune deficiency. Note: Subject using nonsystemic corticosteroids (e.g., topical, ophthalmic, or inhaled) will be eligible for vaccination.
- •11. Subjects who have received a blood transfusion or blood products, including immunoglobulin.
- •12. Prior vaccination of rotavirus vaccine and/or DTP-IPV vaccine (including any component of DTP-IPV vaccine).
- •13. Subjects who have not passed 28 days after live vaccine administration or 7 days after receiving inactivated vaccine.
- •14. Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study.
- •15. Subjects who plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period (visiting grandmother’s home) of time when study visits would be scheduled.
- •16. Subjects who are at high risk of tuberculosis exposure (e.g., subjects living in a household with a person who is under TB treatment or a person with suspected infection with the tubercle bacillus).
- •17. * Inability to obtain blood specimen at randomization visit. Note: Re-schedule visit so that baseline specimen may be obtained prior to the first vaccination
- •18. Subjects whom the physician considers unsuitable to vaccinate.
研究者
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