EUCTR2008-001457-18-ES进行中（未招募）不适用
Single-blind, Randomized, Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点开始时间: 2008年9月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
- •2. Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
- •3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- •4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1.Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- •Any of the following illnesses/conditions that, in the investigator?s judgment, will substantially increase the risk associated with the subject?s participation in and completion of the study:
- •2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •3.Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- •4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •5. Known or suspected immune deficiency or suppression.
- •6. History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
- •7. Major known congenital malformation or serious chronic disorder.
- •8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy.
- •9.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
- •10.Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study.
- •11.Participation in purely observational studies is acceptable.
- •12.Infant who is a direct descendant (child, grandchild) of the study site personnel.
研究者
相似试验
进行中（未招募）
不适用
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy AdolescentsProphylaxis Aganist Invasive Meningococcal DiseaseEUCTR2014-004734-25-Outside-EU/EEAovartis Vaccines and Diagnostics S.r.l.200
尚未招募
2 期
A study on the immunogenicity and safety of GSK Vaccines Global Health multicomponent Shigella vaccine in preventing shigellosis in infantsPaediatricsShigellosisPACTR202402550507294GlaxoSmithKline Biologicals SA200
暂停
2 期
Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer SubjectsCTRI/2013/06/003778OBI Pharma INC342
进行中（未招募）
不适用
Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer SubjectsNeoplasmsKCT0000707Choice Pharma Korea342
进行中（未招募）
1 期
A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 4 hepatitis C infectioHepatitis C infectionMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis CEUCTR2007-005281-12-FRTibotec BVBA