EUCTR2014-003822-42-DK进行中（未招募）不适用
A Phase 4, Single-Arm, Open-Label Study describing the safety and immunogenicity of Bexsero in healthy subjects aged 12 years to <19 years.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Subject eligibility should be reviewed and documented by an appropriate member of the investigator's study team before subjects are included in the study.
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Evidence of a personally signed and dated informed consent/assent
- •document indicating that the subject (and a legally acceptable
- •representative/parent(s)/legal guardian, if applicable) has been
- •informed of all pertinent aspects of the study.
- •2. Subjects (and legally acceptable representative/parent(s)/legal
- •guardian, if applicable) who are willing and able to comply with
- •scheduled visits, treatment plan, laboratory tests, and other study
- •procedures.
- •3. Male or female subjects aged 12 years to <19 years at the time of enrollment.
- •4. Available for the entire study period and can be reached by telephone.
- •5. Healthy subject as determined by medical history, physical
- •examination, and judgment of the investigator.
- •6. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study (through the persistence blood draw visit at Month 7).
- •7.Negative urine pregnancy test for all female subjects who are
- •biologically capable of having children.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 102
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Previous vaccination with any meningococcal serogroup B vaccine.
- •2. Subjects who have received any non-live vaccine (or intramuscular/sublingual allergen immunotherapy) within the previous 14 days or live vaccine within the previous 28 days of study vaccination.
- •3. Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- •4. A previous anaphylactic reaction to any vaccine or vaccine-related component, including kanamycin and latex.
- •5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •6. A known or suspected defect of the immune system that would
- •prevent an immune response to the vaccine, such as subjects with
- •congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or
- •those receiving immunosuppressive therapy. Additional details will be
- •provided in the study reference manual (SRM).
- •7. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- •8. Significant neurological disorder or history of seizure (excluding
- •simple febrile seizure).
- •9. Receipt of any blood products, including immunoglobulin, within 6
- •months before the first study vaccination.
- •10. Current chronic use of systemic antibiotics.
- •11. Participation in other studies involving investigational vaccines,
- •drugs, or devices within 28 days before the current study begins and during study participation. Participation in purely observational studies is acceptable.
- •12. Other severe acute or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere
- •with the interpretation of study results and, in the judgment of the
- •investigator, would make the subject inappropriate for entry into this study.
- •13. Pregnant female subjects, breastfeeding female subjects, male subjects with partners currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the
- •duration of the study (through the persistence blood draw visit at Month 7).
- •14. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
研究者
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