EUCTR2009-014493-18-DE进行中（未招募）不适用
A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered inEither 2- or 3-Dose Regimens in Healthy Subjects Aged =11 to <19 Years
Pfizer Inc 235 East 42nd Street, New York, NY10017 US0 个研究点目标入组 1,714 人开始时间: 2010年7月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,714
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 (ICD) 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
- •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 (ICD) 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 seizure).
- •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.
- •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 seizure).
- •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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