EUCTR2021-004053-23-ES进行中（未招募）1 期
A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 168 人开始时间: 2021年12月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
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 a review of medical history and physical examination) based on the clinical judgment of the investigator.
- •2. Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age (based on a review of medical history), respectively.
- •3. Is male or female, from approximately 11 months to 13 months of age (=327 days to =396 days) inclusive, at the time of obtaining the informed consent.
- •4. A legally acceptable representative has provided documented informed consent for the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •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 known or suspected impairment of immunological function.
- •2. Has known or history of functional or anatomic asplenia.
- •3. Has a known hypersensitivity to any component of the study vaccine.
- •4. Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system.
- •5. Has a bleeding disorder contraindicating intramuscular vaccination.
- •6. Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection.
- •7. Was born to a mother with a known history of hepatitis B infection.
- •8. *Had a recent febrile illness (defined as rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring at or within 72 hours prior to receipt of study vaccine.
- •9. Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
- •10. Has an uncontrolled neurologic disorder or uncontrolled epilepsy.
- •11. Has a health or developmental disorder that, based on the clinical judgment of the investigator, could affect evaluation of the vaccine.
- •12. Has received or is expected to receive immunosuppressive agents during the conduct of the study.
- •13. *Meets 1 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/d for persons weighing >10 kg) for =14 consecutive days and has not completed treatment at least 30 days before study entry.
- •b. Has received any systemic corticosteroids within 14 days before study vaccination.
- •c. Is expected to require any systemic corticosteroids during conduct of the study.
- •14. *Has received any licensed, non-live vaccine within the 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine prior to Visit 2 blood draw.
- •Exception: Participant may receive nonstudy pediatric licensed non-live vaccines on same day as study vaccine is given (Day 1).
- •Exception: Non-live influenza vaccine may be administered, but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine.
- •15. *Has received any licensed live vaccine within 30 days before receipt of study vaccine or is scheduled to receive any live vaccine prior to Visit 2 blood draw.
- •16. *Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
- •17. *Has participated in another clinical study of an investigational product within 2 months before study vaccination at Visit 1 (Day 1) or plans to participate anytime during the duration of the current clinical study. Participants previously or currently enrolled in a COVID-19 vaccine clinical study, or enrolled in observational studies may be included; these should be reviewed on a case-by-case basis for approval by the Sponsor.
- •18. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
- •For items with an asterisk (*), if the participant meets these exclusion criteria, Visit 1 may be rescheduled for a time when these criteria are not met.
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