EUCTR2013-002454-78-PL进行中（未招募）不适用
A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine when administered to Immunocompromised Patients from 2 to 17 years of age who are at Increased Risk of Meningococcal Disease because of Complement Deficiency or Asplenia compared to matched Healthy Controls
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 150 人开始时间: 2014年4月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •In order to participate in this study, all subjects must meet ALL of the inclusion criteria applicable to the relevant group.
- •Inclusion criteria applicable to All Groups (A, B and C)
- •1.Subjects aged 2 to 17 years (inclusive) at enrollment;
- •2.who have given written informed assent (if appropriate) and whose parent/legal guardian have given written informed consent after the nature of the study has been explained;
- •3.available for all the visits scheduled in the study;
- •4.weighing at least 13 Kg at the time of enrollment.
- •Inclusion criterion applicable to Group A
- •5.Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies:
- •a.Primary deficiencies: patients with a congenital condition leading to a reduced concentration of one or more proteins in the complement cascade, including C1 (q,r,s), C2, C3, C4, Factor D, Properdin, C5, C6, C7, C8, C9, Factor H, Factor I (homozygous)
- •b.Secondary deficiencies: patients with a condition indirectly leading to a reduced concentration of one or more proteins in the complement cascade, including patients who are already in treatment with eculizumab at the time of enrollment and have been diagnosed with paroxysmal nocturnal hemoglobinuria or with atypical hemolytic uremic syndrome
- •For patients with a secondary complement deficiency the investigator should include in the source documentation evidence of the increased risk of meningococcal disease based on reduced complement protein concentrations or on previous meningococcal infection. This should be documented in the medical records.
- •Inclusion criterion applicable to Group B
- •6.Subjects at risk of meningococcal disease because of functional or anatomic asplenia:
- •a.Congenital anomalies of the spleen, isolated or in association with other splenic anomalies
- •b.Surgical splenectomy, which may occur after significant splenic trauma or other clinical disorders, such as idiopathic (autoimmune) thrombocytopenic purpura
- •c.Autosplenectomy (i.e. infarction) which may occur in patients with sickle cell disease or other haemoglobinopathies
- •For patients with functional asplenia the investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique. Patients with anatomic asplenia or sickle-cell disease do not require assessment of the splenic function.
- •Inclusion criterion applicable to Group C
- •7.healthy immunocompetent subjects, in good health as determined by medical history, physical examination and clinical judgment of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •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
- •Exclusion criteria applicable to All Groups (A, B and C)
- •1. History of any previous immunization with a meningococcal B vaccine at the time of
- •enrollment;
- •2. History of severe allergic reaction after previous vaccinations, or hypersensitivity to
- •any component of the vaccine;
- •3. Known HIV infection;
- •4. History of any progressive or severe neurologic disorder, or seizure disorder
- •(exception: one self-limited febrile seizure is acceptable);
- •5. Contraindication to intramuscular injection or blood drawn;
- •6. Females who are pregnant, planning a pregnancy or nursing (breastfeeding);
- •7. Females of childbearing potential who have not used or do not plan to use acceptable
- •birth control measures, for the 3 months duration of the study. Oral, injected or
- •implanted hormonal contraceptive, barrier methods (diaphragm or condom with
- •spermicide), intrauterine device or sexual abstinence are considered acceptable forms
- •of birth control. If sexually active the subject must have been using one of the
- •accepted birth control methods for at least 60 days prior to study entry
- •8. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all
- •required study procedures for the whole period of the study;
- •9. Intent to participate in another clinical study during this study;
- •10. Family members or household members of site research staff;
- •11. History or any illness/condition that, in the opinion of the investigator, might interfere
- •with the results of the study or pose additional risk to the subjects due to participation
- •in the study.
- •Exclusion criterion applicable to Groups A and B
- •12. Previous known or suspected disease caused by N. meningitidis in the last year;
- •Exclusion criteria applicable to Group C
- •13. Previous known or suspected disease caused by N. meningitidis;
- •14. Known or suspected impairment/alteration of the immune system resulting from, for
- •example, receipt of immunosuppressive/immunostimulant therapy
- •There may be instances when individuals meet all entry criteria except one that relates to
- •transient clinical circumstances (e.g., body temperature elevation or recent use of
- •excluded medication or vaccine). Under these circumstances, a subject may be
- •considered eligible for study enrollment if the appropriate window for delay has passed,
- •inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be
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