EUCTR2009-014493-18-ES进行中（未招募）1 期
A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged more or equal 11 to <19 Years
PFIZER S.L.U.0 个研究点目标入组 1,712 人开始时间: 2010年6月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,712
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 appropriately qualified member
- •of the investigator’s study team before subjects are included in the study.
- •1. Evidence of a personally signed and dated informed consent document indicating that
- •the parent/legally acceptable representative and/or subject has been informed of all
- •pertinent aspects of the study.
- •2. Parent/legally acceptable representative and/or subjects who are willing and able to
- •comply with scheduled visits, treatment plan, laboratory tests, and other study
- •procedures.
- •3. Male or female subject aged =11 and <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. All male and female subjects must agree to practice a form of effective contraception,
- •such as barrier contraception (ie, condom plus spermicide, a female condom,
- •diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral
- •contraceptives or sexual abstinence prior to entering into the study, for the duration of
- •the vaccination period and for 28 days after the last study vaccination. For
- •Germany: The phrase sexual abstinence is not applicable, with the understanding that
- •all male and all female subjects of childbearing potential must practice an effective
- •form of contraception during the study.
- •7. Negative urine pregnancy test for female subjects.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1524
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •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. A previous anaphylactic reaction to any vaccine or vaccine-related component
- •3. Bleeding diathesis or condition associated with prolonged bleeding time that would
- •contraindicate intramuscular injection.
- •4. A known or suspected disease of the immune system or those receiving
- •immunosuppressive therapy.
- •5. History of culture-proven disease caused by Neisseria meningitidis or Neisseria
- •gonorrhoeae.
- •6. Significant neurological disorder or history of seizure (excluding simple febrile
- •7. Receipt of any blood products, including immunoglobulin within 6 months before the
- •first study vaccination.
- •8. Current chronic use of systemic antibiotics.
- •9. Participation in other studies during study participation. Participation in purely
- •observational studies is acceptable.
- •10. Received any investigational drugs, vaccines or devices within 28 days before
- •administration of the first study vaccination.
- •11. Any neuroinflammatory or autoimmune condition, including, but not limited to,
- •transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- •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. Subjects who are investigational site staff members or subjects who are Pfizer
- •employees directly involved in the conduct of the trial.
- •14. Subject is a direct descendant (e.g., child, grandchild or other family member) of study site or Pfizer personnel.
- •15. Subject is pregnant or breastfeeding.
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