EUCTR2014-004446-95-Outside-EU/EEA进行中（未招募）不适用
A Phase IV, open-label, controlled, multi-center study to evaluate the 5-year antibody persistence among children who previously received Novartis MenACWY conjugate vaccine at 2 to 10 years of age and to assess the immune response to a single dose of Novartis MenACWY conjugate vaccine.
ovartis Vaccines and Diagnostics0 个研究点目标入组 500 人开始时间: 2014年11月13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
- 入组人数
- 500
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. Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements.
- •2. If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study.
- •3. Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator.
- •4. A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled.
- •- Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- •5. For subjects who participated in study V59P20 (Groups A, B and D only): subject who enrolled in Groups I, II or IV of study V59P20, has completed this study and included in per protocol immunogenicity analysis; the date of first vaccination in study V59P20 occurred 54 to 66 months prior to the collection of the blood sample at Visit 1.
- •6. For vaccine-naive subjects (Groups C and E only): Individual is a male or female 7 to 10 years of age (group C) or 11 to 15 years of age (Group E).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.(Acceptable birth control methods were defined as one or more of the following: hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring), barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse, intrauterine device (IUD), monogamous relationship with vasectomized partner (partner was to be vasectomized for at least six months prior to the subject’s study entry) and abstinence.)
- •2. Subject is a pregnant or breast-feeding female.
- •3. Subjects’ parents or legal guardians or subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- •4. History of documented or suspected invasive meningococcal disease.
- •5. Previous household contact with and/or intimate exposure to an individual with laboratory proven N. meningitidis infection within 60 days prior to enrollment and for the duration of the study.
- •6. Have received any other meningococcal vaccine since participation in V59P20 or, if vaccine-naive subjects, have received any meningococcal vaccine since birth.
- •7. Suspected or known hypersensitivity reaction after a previous dose of Menveo, any component of this vaccine, including any other CRM197 and diphtheria toxoid.
- •8. Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine as highlighted in the package insert.
- •9. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
- •10. Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
- •11. Administration of any cancer chemotherapy, immune-modified or immunosuppressive agents or systemic corticosteroids for at least seven days at any dose in the past 12 weeks or planned use throughout the study period (topical, inhaled, and intranasal corticosteroids are permitted).
- •12. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks or planned use throughout the study period.
- •13. Administration of any vaccine within 28 days prior to the study enrollment or planned administration during the study period.
- •14. Subjects participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the study period.
- •15. Subjects who have experienced a significant acute infection requiring systemic antibiotic treatment within the 5 days prior to enrolment or have experienced a body temperature =38°C (=100.4°F) within the 3 days before the intended study vaccination.
- •16. Any condition which, in the opinion of the investigator, would pose a health risk to the participant.
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