EUCTR2020-005059-19-FI进行中（未招募）1 期
A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS 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）
- 入组人数
- 150
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 infants born at >36 weeks of gestation and who are 3 months of age (=76 to =104 days) at the time of consent (the day of birth is considered day of life 1).
- •Type of Participant and Disease Characteristics:
- •2.Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •3.Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- •4.Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •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
- •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 (including simple febrile seizure).
- •5.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •6.Family history of congenital or hereditary immunodeficiency.
- •7.Other medical or psychiatric condition, including recent 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.
- •8.Major known congenital malformation or serious chronic disorder.
- •Prior/Concomitant Therapy:
- •9.Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y. Written vaccination history must be obtained prior to enrollment.
- •10.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •11.Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date on enrollment (first vaccination).
- •12.Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone =0.5 mg/kg/day or equivalent. Inhaled and topical steroids are allowed.
- •Prior/Concurrent Clinical Study Experience:
- •13.Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
- •Diagnostic Assessments:
- •Not applicable.
- •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.
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