EUCTR2011-004400-38-FI进行中（未招募）1 期
A Phase 2, Randomized, Controlled, Observer-blinded Study, Conducted to Describe the Immunogenicity, Safety, and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) when Administered to Healthy Toddlers Aged 12 to <18 Months or 18 to <24 Months
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
- 396
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
- •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 document (ICD) indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study (a parent(s)/legal guardian must be over 18 years old to consent for the child to be considered for inclusion in this study).
- •2.Subject must have received all vaccinations in the relevant national immunization program (NIP) for his or her age group.
- •3.Male or female subject aged:
- •12 to <15 months or 18 to <24 months during sentinel-cohort enrollment.
- •12 to <24 months during expanded-cohort enrollment
- •4.Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.
- •5.Subject’s parent(s)/legal guardian is willing and able to comply with the child’s scheduled visits, vaccination regimen, laboratory tests, and other study procedures.
- •6.Subject is available for the entire study period and his or her parent(s)/legal guardian can be reached by telephone.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 396
- •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
- •Subjects presenting with any of the following will not be included in the study:
- •1.Previous vaccination with any meningococcal serogroup B vaccine.
- •2.Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
- •3.Contraindication to vaccination with any HAV vaccine or known latex allergy.
- •4.Receiving any allergen immunotherapy.
- •5.A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •6.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •7.A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Please refer to the study reference manual (SRM) for additional details.
- •8.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- •9.Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
- •10.Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
- •11.Current chronic use of systemic antibiotics.
- •12.Current participation in another investigational study. Participation in purely observational studies is acceptable.
- •13.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
- •14.Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- •15.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.
- •16.Subjects who are children of investigational site staff members or relatives of those site staff members or subjects who are children of Pfizer employees directly involved in the conduct of the study.
研究者
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