EUCTR2018-002588-24-PL进行中（未招募）1 期
A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA® WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS =10 YEARS OF AGE
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
- Pfizer Inc.
- 入组人数
- 50
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
- •Age and Sex:
- •1. Male or female participants =10 years of age at the time of consent.
- •Type of Participant and Disease Characteristics:
- •2. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •3. Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies (including but not limited to C5-C9, properdin, factor H, or factor D).
- •4. Available for the entire study period and can be reached by telephone.
- •5. Female participants of childbearing potential must agree to use a highly effective method of contraception through at least 28 days after the last study vaccination. A participant is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active. This criterion is not applicable to male participants.
- •6. Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
- •Informed Consent:
- •7. Participants who are, or whose parent(s)/legal guardian(s) are, capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical Conditions:
- •1. A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •2. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •3. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- •4. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- •5. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- •6. Any confirmed or suspected human immunodeficiency virus infection, based on medical history and physical examination (no laboratory testing required).
- •7. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Prior/Concomitant Therapy:
- •8. Previous vaccination with any meningococcal serogroup B vaccine.
- •9. Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- •10. Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
- •11. Current chronic use of systemic antibiotics.
- •12. Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab).
- •Prior/Concurrent Clinical Study Experience:
- •13. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
- •Other Exclusions:
- •14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- •15. Pregnant female participants; breastfeeding female participants; female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception
研究者
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